Monday, July 15, 2024

Philips Issues Recall for BiPAP V30, A30, A40 Ventilators

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Philips Respironics, Inc. has issued a recall for the BiPAP V30, BiPAP A30, and BiPAP A40 devices due to significant safety concerns. This recall involves updating instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. Continued use without following the updated instructions may cause serious injury or death.

The affected products include the BiPAP V30, BiPAP A30, and BiPAP A40. Specific details such as the Unique Device Identifier (UDI)/Model and lot/serial numbers can be found on the FDA’s recall notice. If therapy interruptions can be tolerated and the ventilator inoperative (vent inop) alarm occurs, follow these steps: Remove the patient from the device and place the patient on an alternative device.

If therapy interruptions cannot be tolerated, patients and caregivers should provide alternate ventilation and contact the equipment supplier for an immediate device alternative. On March 26, 2024, Philips Respironics, Inc. sent all affected customers an URGENT Medical Device Recall recommending the following actions: If a Ventilator Inoperative Alarm occurs, immediately remove the patient from the device and connect them to an alternate source of ventilation, if available.

As an optional action, attempt a “hard reboot” to temporarily restore device function. Identify customer lists and where appropriate, distribute this Urgent Medical Device Recall Notice and all relevant appendices to physicians, clinicians, patients, and/or users. Complete and return the response form included in the notice. Philips Respironics, Inc. is updating the use instructions for V30, A30, and A40 ventilators due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss.

recall

Philips Recalls BiPAP Ventilators Due to Safety Risks

The device may reboot intermittently for 5-10 seconds (stopping therapy, blank screen, single audible alert), then restart with the same patient settings or with factory default settings. It may enter a Ventilator Inoperative state (therapy stopped, audible and visual alarms present) after three reboots within 24 hours or without a preceding reboot. These issues can result in therapy interruption or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients. There have been 952 reported injuries and 65 reports of death.

The BiPAP V30 Auto ventilator provides non-invasive support for adults and children over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA) and respiratory insufficiency. It is for use in institutions or hospitals and is not for life support but can be used during intra-facility transport. The BiPAP A30 ventilator provides non-invasive support for adults and children over 10 kg (22 lbs) with OSA and respiratory insufficiency.

It is suitable for home use and clinical settings such as hospitals, sleep labs, and intermediate care institutions. The BiPAP A40 Pro ventilator provides invasive and non-invasive support for adults and children over 10 kg (22 lbs) with OSA, respiratory insufficiency, or respiratory failure. It is not for life support or transport use but is intended for home and clinical settings, including portable applications like wheelchairs and gurneys.

Philips has been proactive in addressing this issue to ensure patient safety. The company is committed to correcting the affected devices with a software patch and providing replacement devices where necessary. Philips encourages all affected customers to follow the updated instructions carefully to avoid any potential harm. The recall underscores the importance of adhering to medical device instructions and promptly addressing any alerts or malfunctions. Patients and caregivers are urged to remain vigilant and report any adverse events to the FDA.

Philips Respironics, Inc. has taken significant steps to rectify the issues with the BiPAP V30, A30, and A40 ventilators, ensuring that all affected devices are updated or replaced to prevent serious injury or death. This recall highlights the critical nature of medical device safety and the continuous efforts required to maintain it.

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Resource: U.S. Food and Drug Administration, June 27, 2024

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