Device safety informationMHRA
Philips Respironics BiPAP A series ventilators safety warning over a software fault
Philips Respironics has issued a Field Safety Notice (FSN) relating to the Bilevel Positive Airway Pressure (BiPAP) A series ventilators. This relates to a Ventilator Inoperative alarm which could result in the potential loss of therapy to patients without warning.
What to do now
Philips Respironics BiPAP A series ventilators may show incorrect information or fail to alert as expected.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. Software faults can lead to wrong readings, missed alarms or incorrect settings.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2024/006). Quoted as issued.
Summary
Philips Respironics has issued a Field Safety Notice (FSN) relating to the Bilevel Positive Airway Pressure (BiPAP) A series ventilators. This relates to a Ventilator Inoperative alarm which could result in the potential loss of therapy to patients without warning.
The risk
Update: May 2025 Philips Respironics have published a Field Safety Notice (FSN) to further clarify the patient population who cannot tolerate interruptions or loss of therapy. Please see the FSN for further information. The advice within this DSI remains unchanged. Patients should continue to follow the advice of their healthcare professional. Update: 2 October 2024
Advice for healthcare professionals
Actions for healthcare professionals
Identify patients using the relevant devices listed in the FSN in both inpatient and community-based settings
Follow the actions set out in the FSN
Assess if patients can tolerate interruptions to their therapy.
If patients cannot tolerate interruptions of therapy, prioritise and provide an alternative device appropriate to their level of ventilation dependency as soon as possible depending on local resources.
If patients can tolerate interruptions in therapy, consider the benefits and risks of continued use on an individual basis. Prioritise patients at higher risk to ensure an alternative device is provided at the earliest opportunity depending on local resources. Lower risk patients should also be provided with an alternative device when possible depending on local resources.
For patients using this device who have a backup device available, advise the patients / carers or caregivers or hospital staff that if the alarm occurs to immediately remove the device, and connect the patient to an alternative device.
Ensure community-based patients/carers or caregivers are provided with clear instructions for changing over their device.
As an additional measure, a forced restart of the device may temporarily restore function of the device if it has entered the inoperable state whilst waiting for a replacement device:
Power off the device by pressing the start/stop button. If the ventilator screen displays the “Power off” command, then press the “Yes” button to shut off the device and silence the alarm
Unplug the power cord from the wall or from the device itself
Remove the battery from the ventilator device. If a detachable battery pack is used, open the battery compartment at the top of battery module accessory and lift out the battery using the release lever on top of the battery. If an external battery pack is used, unplug the battery pack cord from the back of the ventilator
Open the MHRA notice
Questions
Why has Philips Respironics BiPAP A series ventilators been recalled?
Philips Respironics BiPAP A series ventilators may show incorrect information or fail to alert as expected. Software faults can lead to wrong readings, missed alarms or incorrect settings.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.