Respironics California, LLC Recalls
Showing 1-5 of 5 recalls
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
On 10/30/2020, the firm sent an "URGENT-MEDICAL DEVICE CORRECTION" Notification Letter via priority mail informing customer that the Ventilators may experience two potential issues with the battery (see table below for additional information). 1. The ventilator may exhibit a high priority Check Vent: Battery Failed alarm if the battery is allowed to over discharge. 2. The battery may fail to charge if the ventilator is stored for an extended period of time without being plugged into AC power. If the ventilator exhibits a high priority Battery Failed alarm while connected to AC power, the V60 ventilator will annunciate an audible and visual alarm. The ventilator will continue to deliver prescribed therapy; however, the audible and visual alarm will continue until the device is powered down; therefore, the patient should be transferred to an alternate source of ventilation as soon as one becomes available. The hazard associated with transferring a patient to an alternate source of ventilation is a temporary loss of therapy leading to potential hypercarbia or hypoxemia (moderate). If AC power fails and the backup battery is not functioning, an audible and visual alarm will annunciate for at least two minutes. The ventilator will no longer be operative resulting in a total loss of therapy. The patient will require an alternate source of ventilation. The hazard associated with a ventilator shutdown is a total loss of therapy leading to potential hypercarbia or hypoxemia (severe). Customers are instructed: Follow the instructions in the V60 user manual and the instructions below to reduce any risk associated with potential battery issues. 1) Avoid allowing the ventilator battery to become completely discharged. Otherwise, the battery may become over-discharged and require long recharge times of up to 16 hours or more. The over-discharged condition may permanently damage the battery so that it is unable to recharge. To prevent the occurrence o
Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.
On 06/18/2021, the Recalling Firm sent an "URGENT - Medical Device Recall" Notification Letter via USPS certified mail to customers informing them that a problem has been detected in their ventilators that could pose a risk to patients or users. All units with High Flow Therapy option (Software Versions 3.00 and 3.10) are impacted. These ventilators with the High Flow Therapy software were designed with a safety mechanism to limit the amount of pressure that can be delivered to the patient when the ventilator is operating in High Flow Therapy. In situations where the high flow therapy pressure reaches the maximum limit, the ventilator will sound a low priority "Cannot Reach Target Flow (CRTF) alarm and reduces the pressure which also simultaneously decreases the flow rate to a level below what was set by the clinician for as long as the condition persists. Customers are instructed/informed to: When administering HFT via High Flow Nasal Cannula the following action must be taken: (1) Monitor the patients SpO2 continuously; (2) All patients that are dependent on supplemental oxygen, and at risk of clinical deterioration should be under constant and close monitoring by the clinician to prevent dangerous drops in blood oxygen levels, work of breathing and respiratory distress and resulting escalation in medical treatment (3) Respond to all alarms urgently, regardless of alarm priority; (4) If the patient cannot be constantly and closely monitored by the clinician, do not use High Flow Therapy. In addition; (5) Refer to and follow the attached user manual addendum titled V60 Plus User Manual Addendum: High-Flow Therapy Safety and Alarm Features. This user manual addendum provides additional technical details about the CRTF alarm functionality. The addendum is also available at www.philips.com/hrcmanuals under the V60/V60 Plus link titled "V60 Plus User Manual Addendum - High-Flow Therapy Safety and Alarm Features. For additional information and educ
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Due to unqualified "design verification" batteries being shipped to customers.
On 01/06/2021, the firm contacted via telephone calls and then on 01/29/2021 sent a follow-up "URGENT - Medical Device Removal" letter via priority mail to customers to inform them that the Recalling Firm shipped unqualified batteries to customers. These batteries are similar to production batteries but did complete final qualification testing. Potential hazards that may result, In a worst-case scenario, a battery failure could occur while in use on a patient during intra-hospital transport or when not connected to AC power. In both situations, the patient could lose ventilatory assistance and experience severe hypoxemia. Customers are provided instructions on how to identify affected products: Check the label of backup batteries (PN 1076374) received on or after November 25, 2020, or installed on affected units. If the battery has LOT M94663-P1, it is affected. Customers are instructed to: 1. If the batteries have been installed in ventilators, remove the ventilators from service until a field service representative or approved service provider schedules a visit and replaces the battery. 2. If waiting for a field service representative or approved service provider is not possible given their current census, contact Recalling Firm by email at HRC.Recall.Response@Philips.com to request a replacement battery that trained biomed can install. 3. If the affected battery has not been installed in a ventilator, quarantine the battery until a Recalling Firm representative can replace it. 4. Complete, sign, and return the Acknowledgment and Receipt Form at the end of this letter. For further information and questions - contact the local representatives or Customer Care Solutions Center (24/7) +1-800-722-9377
Philips V60 Ventilators with Power Management PCBA part number 1055906
Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia
On 03/05/20 Urgent Medical Device Correction Field Safety Notices were mailed to customers. Customers were informed that it is not necessary to remove affected V60 ventilators from service due to the rarity of these failure modes. Customers were asked to do the following: From the Operator's Manual: 1. Use an external O2 monitor/analyzer and set the ventilator alarm thresholds appropriately. 2. Promptly attend to all alarms presented by the ventilator. 3. Ensure that an alternative means of ventilation is available whenever the ventilator is in use. Additional directions: 4. Follow the above procedure to determine whether the V60 ventilator is affected by this correction without interrupting therapy. 5. If a V60 ventilator experiences a shutdown, disconnect the patient and immediately start ventilation with an alternate device. Contact a local customer service contact to report the failure and to schedule corrective maintenance. 6. Acknowledge receipt of this notification by fax or e-mail. The firm notified customers that once Power Management PCBAs are available, you will be contacted by your approved service provider to schedule a corrective maintenance to replace the Power Management PCBA at a time when the ventilator will not be in use. In addition, customers were asked to review the information with all staff members who need to be aware of the contents of the communication. Retain a copy of this notice and include with the equipment Instructions for Use. Distributors were informed: It is imperative that all end-users with affected Ventilators listed in the "AFFECTED PRODUCTS" section of this FSN, receive this Medical Device Correction notice. Because the firm sells these products through distributors, including your organization, we may not have the information to contact all users. Therefore, send a copy of the attached Field Safety Notice to any customer to whom you have distributed one of the affected devices. Note: the firm has sen
Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
On 09/26/19, Urgent Medical Device Correction Field Safety Notices were mailed to customers. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (Ventilator): 1) If in use on a patient, continue to use the ventilator if an alternative non-invasive ventilator is not available. 2) If a touchscreen failure is detected, disconnect the patient and immediately start ventilation with an alternate device. Contact your local customer service representative to report the failure. 3) To minimize the risk of patient injury, operate the Ventilator as defined in the operator's manual and promptly attend to all alarms presented by the ventilator. 4) As recommended in the operator's manual, use an external 02 monitor/analyzer and set the alarm thresholds appropriately. 5) As recommended in the operator's manual, have an alternative means of ventilation available whenever the ventilator is in use. 6) Acknowledge receipt of this notification. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (User Interface RP-Kits): 1) If the affected kit is installed on a ventilator and in use on a patient, continue to use the ventilator if an alternative non-invasive ventilator is not available. 2) If the affected kit is installed on a ventilator, document the serial number of the ventilator and the serial number of the affected User Interface Assembly it contained, on the attached Acknowledgement and Receipt Form. 3) If the affected devices could not be found or linked to a ventilator at your site, please indicate this within in the detail section provided on the form, 4) Return the completed and signed Acknowledgement and Receipt Form. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (Tou