Draeger Medical, Inc. Recalls
Showing 21-40 of 42 recalls
Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventil
Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Drger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR. A
A recall notification letter, dated March 2014, was sent to wholesale distributors and end users.
Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.
The firm, Drager, sent an "Urgent Medical Device Recall" letter dated August 2013 to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that in the event of a failure, manual ventilation mode should be used and that Draeger reps would be contacting customers to schedule the replacement of the power supply. The customers were instructed to notify personnel accordingly. If you have any questions, contact Director, Quality at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DragerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches).
An "Urgent Medical Device Recall" notification letter was sent to users in September 2013. The issue was described and recommended actions were provided. Customers may contact (800) 543-5047 and select 1, then 2.
Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).
Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements.
Firm initiated their recall of this device on October 25, 2011 by sending an "Urgent Medical Device Recall" letter to consignees. A Technical Service Bulletin will be generated and distributed globally that instructs the affected International Draeger subsidiaries to inform customers in their countries. The software anomaly has been corrected in software version 7.3. Draeger Service Representatives will schedule time with customers to upgrade the software in affected monitors. The software upgrade will be provided free of charge.
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.
Drager sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-543-5047 for questions relating to this notice.
Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.
During product training on the Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values. In addition, a misalignment of ECG and ART waveforms delivered from an Infinity(RO Acute Care System (IACS) Monitoring Solution (M540) was observed on the Infinity Central Station.
The firm initiated their recall of this device on October 17, 2011 by issuing a letter to the consignee instructing customers to follow the Instructions for Use and use the Infinity Central Station only for remote assessment of a patient's status. They recommend that you do not consider the waveforms on Infinity Central Station for primary diagnosis purposes. In case of a high priority alarm situation, "Check the patient and treat if necessary". If the misalignment issue is observed, it can be cleared by undocking and redocking the M540 or by changing the order of waveforms displayed on the Cockpit screen (or any other change to the auto display screen layout).
Delta/Delta XL Monitors with Omega S Package
monitor is rebooting/resetting
Draeger Medical Systems, Inc. issued and Urgent Medical Device Recall letter dated November 2009 to their affected customers informing them of the problem and a work around until software can be validated. A Technical Service Bulletin has been generated and distributed globally that instructs the affected International Drager subsidiaries to inform customers in their countries. For further information, contact Draeger Medical Systems, Inc. at 1-800-543-5047, extension 1-2349.
Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.
The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.
The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.
Drager Surgical Lights Sola 500 and Sola 700.
welded seam may fail
Draeger Medical, Inc. issued a "Medical Device Recall" letter dated August 2009 via certified mail with return receipt. Consignees were informed on the affected product and that a service representative will be in contact shortly to schedule a replacement. For further information, contact Draeger Medical at 1-800-543-5047, press 1 at the prompt and then 2349.
Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.
The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.
An "Urgent - Medical Device Recall" Letter dated January 2009 was issued to consignees via certified mail. The letter described the issue, specific conditions, background information, and precautions for customers. An additional letter dated January 22, 2009 was included with the "Urgent - Medical Device Recall" letter which instructed consignees to inform an enduser of the contents of the notification letter because some of the consignees are home care device/service providers. When the new hardware/software solution is available, affected devices will be updated free of charge. Direct questions about the notification letter to Drager Medical, Inc. by calling 1-800-543-5047 (press "1" at the prompt and then press "2349#"). Direct questions regarding updating your device when the new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press "4" at the prompt).
Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
May experience an interruption of ventilation for approximately 5 seconds
The firm issued an Urgent - Medical Device Recall letter dated September 2008. Software version 1.10 may under specific conditions experience an interruption of ventilation for approximately 5 seconds. During that time period, the patient airway pressure may drop to zero. This phenomenon was identified by Draeger engineers and to date has not been reported by any user. The firm's investigations revealed that when ventilating in BIPAP mode with the pressure rise time (Ramp) set to the highest setting and the expiration time set to exactly 0.5 seconds, the inspiration phase can coincide with the internal auto zero function of the device. Under these circumstances a pressure spike will occur upon reaching Pmax +5mbar (cmH2O) which with software version 1.10 will lead to the inspiratory phase stopping. Ventilation will resume after approximately 5 seconds. The device will generate a Paw Measurement INOP alarm. Until the new software is available, customers are being instructed to avoid the use of the following combination of settings: 1) BIPAP mode; 2) Ramp = highest, and 3) Texp = 0.5 seconds.
Evita 2 dura Critical Care Ventilator. Continuous (Respirator)
Audible power failure alarm was not enunciated at the required volume
The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/2/08 informing the consignees of the problem and the need to have the circuit board replaced.
Draeger Medical Apollo Anesthesia Machine, catalog number 8606500
Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages function as designed.
Draeger Medical sent a Medical Device Recall letter to their customers via certified mail on 8/22/08 informing them of the problem. Until the exchange of affected printed circuit boards has been implemented, the firm is recommending that users closely monitor all device displays and error messages and if applicable act in accordance with the advisory statements and remedial information provided in the Instructions for Use as well as making provisions for alternative patient care measures.
Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
The recaling firm issued a recall letter to the US customers 11/17/2006 via certified mail. An authorized service representative will inspect each potentially affected unit. If a unit is found to have an affected docking station, the unit will be repaired or replaced free or charge. Notification to international customers will occur through the international subsidiaries.
Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.
Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.
Consignees were notified by an Urgent Medical Device Recall letter sent on 2/7/08. The letter informed users that the recalling firm will contact them to schedule appointments to inspect any potentially affected machines. The letter instructed users to continue using the machines, before the inspection, making sure to carefully follow the warnings in the instruction manual. If a caster on the machine appears unstable before the inspection is conducted, users were advised to contact the recalling firm. For additional information, contact 1-800-543-5047.
Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.
The firm notified consignees on 2/1/08, by an Important Safety Notice. The letter instructed users to remove any units from use until a Draeger Service Representative can replace the power board. A Service Representative will be in contact to schedule a service visit. For questions concerning this recall please contact 215-660-2418 or Anbu.arasu@draeger.com.
Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
Failure to generate an alarm when an unintended disconnection occurrs
Recalling firm has issued a medical device recall letter to consignees to the attention of the Director, Neonatal Intensive Care Unit via Certified Mail to alert them of additional monitoring requirements if a PEEP setting of less than 2.5 mbar is used
Fabius GS Anesthesia Machine. Catalog number 8604699
One of four casters may break loose from chassis
The recalling firm issued recall letters to their customers 10/03/2006 to inform them of the problem and that a service represenative will contact them to schedule an inspection of their machines. Should the inspections revealed any affected machines, the machines will be repaired free of charge.
APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.
rotating knob of the rotary style APL valve can become separated from the assembly.
The recalling firm issued a letter to their accounts informing them of the problem. The letter also informed the accounts that they would be contacted when the replacement knob was available to schedule the correction.
Medical Air Compressor Model #8413419
Compressors not providing sufficient supply pressure to connected medical ventilator
The recalling firm issued a Medical Device Recall Letter dated 1/22/07 to their customers via Certified Mail. An authorized service representative will inspect each potentially affected device. If a device is found to have an affected dryer assembly, it will be repaired free of charge.