This action is superseded by the Update on product defect issued in June 2024.
Philips is advising of interruptions and/or loss of therapy with the potential for unexpected shut down of the A30 and A40 series bi-level positive airway pressure (BiPAP) devices due to a Ventilation Inoperative Alarm.
All the following devices are affected:
- BiPAP A30
- BiPAP A40
- BiPAP A40 EFL
- BiPAP A40 Pro.
What is the problem?
This problem may appear in any of the following ways:
- The device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarts therapy, and returns to delivering therapy with same patient settings or with factory default settings.
OR
- When there are three (3) reboots within a 24-hour period, the device will enter a Ventilator Inoperative state (therapy stopped, audible and visual alarms present).
OR
- The device may enter a Ventilator Inoperative state without a reboot preceding this condition.
Philips Respironics is currently investigating this issue.
What are the risks?
If any of the above situations occur it could result in interruption and/or loss of therapy which may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
What should patients do?
For home-based patients, immediately contact your healthcare/equipment provider for assistance or call Philips Customer Support on 1800 830 517.
It is recommended that:
- patient monitoring equipment is used (i.e., an alarming Pulse Oximeter or Respiratory Monitor)
- an alternative source of ventilation is used if you are concerned about adverse impact on your health.
For patients that cannot withstand interruptions or loss of therapy, it is strongly recommended that:
- a caregiver should closely monitor the patient
- the patient is removed from the device and placed on an alternative source of ventilation as soon as possible.
What should health professionals do?
Prior to placing a patient on the ventilator, please refer to the user manual (including contraindications) and perform a clinical assessment to ensure that:
- the device is appropriately set for patient requirements
- alternative ventilation equipment is available, and
- where appropriate, alternative monitoring (i.e. an alarming Pulse Oximeter or Respiratory Monitor) is used.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.