Draeger Medical Systems, Inc. Recalls
Showing 1-12 of 12 recalls
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physici
Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
The firm, Drager, sent an "Urgent Medical Device Safety Notices" were distributed to customers on 5/15/18. The letter described the product, problem and actions to be taken. The letters instruct customers to perform the following: Enclosed with this letter are label/s and instructions on how and hwere to apply the label onto your device/s. Please make sure that all JM-105/JM-103 devices in your hospital are labeled according to the instructions in a timely manner. Please make sure that in your clinical environment the users are trained in the use of the equipment and the clinical workflow is set up in a way that the device is not used as a diagnostic device. In case of any uncertainty (e.g. risk factors cannot be evaluated), a blood test needs to be performed. The risk factors according to the Guideline of American Academy of Pediatrics are summarized in the attached Sample Usage Protocol Template as well as the recommended method to use the device as intended in a clinical environment. Please completed and return the attached Customer Reply card. If you have any questions regarding, please call 1-800-437-2437(press 1 at the prompt than 32349) between the hours of 8:00am-4:30pm EST.
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
On May 20, 2022, the firm began to send Important Field Safety Notice letters to affected customers. Customers were instructed to avoid using the ventilator portion of the system due to the potential for enriched ambient air rising beyond safe levels until a replacement part can be installed and tested. The firm will send customers a replacement kit and testing which will be completed at no charge to the customer. Draeger Service Representatives will call customers and schedule a service visit to update affected systems.
Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Drager sent an Urgent Medical Device Recall letter dated February 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an affected device for patient transport only if absolutely necessary; not to rely on the battery charge status indicator, always supervise the patient and the ventilator during transport; ensure that they have a manual breathing bag available for manual ventilation as recommended in the instructions for use. If the power fail alarm occurs during transport, immediately provide manual ventilation and connect ventilator to a wall power source to resume ventilation. DragerService representative will schedule the implementation of a permanent solution as quickly as possible. The letter should be distributed to users of the Evita V500 and /or Babylog VN500 Ventilators to make them aware of this device behavior and risk mitigation measures. Customers with questions were instructed to call 1-800-543-5047. For questions regarding the operation and/or servicing of their Draer ventilator contact Technical Support at 1-800-543-5047. For questions regarding this recall call 215-721-5400.
Draeger Infinity Acute Care System Monitoring Solution
After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
An Urgent Medical Device Recall Letter, dated December 2013, was sent to Users. Once available Drager will update components of the IACS Monitoring Solution System.
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
Drager sent an Urgent Medical Device Recall letter dated February 2014 to affected customers. The letter identified the affected device, problem and actions to be taken. The notification directed customers to perform manual ventilation in the event of a failure. Drager plans to repair the affected devices free of charge. If you have any questions regarding the Recall letter please call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger ventilator please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Drager PT 4000 Phototherapy System
A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b
Drager Medical Systems sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 2012 to all affected customers. The letter identifies the product, problem, and actions to bee taken by the customers. In addition, a Customer Reply Card was included for customers to complete and return. Contact the firm at 800-543-5047 for questions regarding this recall.
Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
Draeger Medical sent an "Urgent Medical Device Recall Notification" letters dated July 2011 to all affected customers. The letter included product and problem affected. The letter informed the customer a Draeger representative will contact them to upgrade the system. Until the solution is implemented, Draeger recommends the Delta and/or Gamma XXL may be used. If the affected monitors become inoperative or activate without user interaction, Draeger advises removing the monitor from service and contacting a Draeger representative. For questions or for information on this recall please call Draeger Service at (800) 543-5047 (press 1 at the prompt, then 2, then 32349).
Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
Draeger Medical issued "Urgent-Medical Device Recall Notification" letters to affected consignees. The Delta/Gamma X XL monitor keyboards will be updated with new material at each affected facility. If the keys on affected monitors become inoperative or activate without user interaction, the customer is instructed to remove the monitor from service and contact Draeger at 978-379-8573. A Technical Service Bulletin (TSB) will be distributed globally, instructing subsidiaries to inform international customers.
Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 inhalation anesthesia machine for use in operating, induction and recovery rooms
potential failures to Electri-Cord Manufacturing AC power cord
Draeger Medical, Inc., sent an Urgent - Medical Device Recall letter dated August 2010 to all customers. The letter described the product, the problem, and actions to be taken by the customer. Customers were instructed to: 1) Immediately take the cord out of service if the plug has bent or cracked prongs, burned plastic, or shows signs of excessive wear. 2) Monitor the affected cords regularly and be mindful of excessive wear and tear, misuse, or abuse until the affected cord is replaced. 3) Customers were also asked to complete and return the enclosed Customer Power Cord Form via mail: Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969; fax: 1-215-721-5808; or e-mail: kathy.benedetto@draeger.com. 4) Disable the cords by cutting off the plug and dispose of the cord in accordance with their facility's disposal procedure when affected power cords are removed. NOTE: The firm will send replacement power cords free of charge. Draeger will only replace power cords originally provided by Draeger (identified with the white flag/part number 4117266. If you have any questions regarding this letter please call 1-800-543-5047 (press 1 at the first prompt, 2 at the second prompt and then 32349#).
Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.
On 7/20/09, Draeger Medical, the recalling firm, issued a press release to medical media outreach organizations and an Urgent Medical Device letter to all known customers. This information explained the incident and the need to remove and replace the units in question as soon as feasibly possible.
Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.
The firm sent Important Safety Notice Letter, dated August 2010, and Instructions for Use supplement to consignees. The letter explained the issue with the affected product. The letter asks customers to attach the Instructions for Use amendment sheet supplied with the letter to their corresponding Instructions for Use. The firm also states that a they will provide a dedicated pediatric breathing circuit for the Oxylog 3000. Questions regarding the letter should be directed to Michael Kelhart at 1-800-543-5047. Questions regarding the use of the device should be directed to DragerService Technical Support at 1-800-543-5047 or your local Drager Sales Representative.
Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.
Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.
Draeger Medical issued an Urgent Medical Device Recall letter via certified mail on 8/7/09. The letter explained the problem, the need to conduct an inspection of the infant warmer (instructions included), and request replacement elements.