Philips updates safety notice for certain BiPAPs
By HME News Staff
Updated 11:18 AM CDT, Tue May 28, 2024
AMSTERDAM – Philips has provided an update on a field safety notice affecting certain Philips Respironics ventilators due to a potential device alarm-related issue.
The company first notified customers of the safety notice in March.
Philips provided the following update:
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Philips Respironics notified customers of the BiPAP A30, BiPAP A40, BiPAP V30 and OmniLab Advanced Plus ventilators of a potential issue affecting approximately 100,000 units.
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Under certain circumstances, the ventilator inoperative alarm, which detects an internal error or condition that could affect therapy, may incorrectly engage. In this event, the ventilator will shut down, in accordance with the intended function of the alarm.
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There have been no reports of patient harm for BiPAP V30 or OmniLab Advanced Plus units, and a limited number of possible rare patient adverse events for the BiPAP A30 and BiPAP A40 devices.
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Regarding BiPAP A30 and BiPAP A40 devices, the company has received 10 reports alleging serious injury, and seven reports of patient death potentially associated with this issue over a 12-year period, between 2011 and 2023. Investigation of these reports could not conclusively determine causation.
Philips says customers may continue to use their system in accordance with device instructions for use and the field safety notice.
It also says it is currently investigating this issue and will implement appropriate actions to prevent recurrence.
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