AMSTERDAM – Philips has issued updated use instructions for its BiPAP V30, A30, and A40 ventilators following concerns over a potential malfunction in the “Ventilator Inoperative” alarm system, which could interrupt or halt therapy.
The U.S. Food and Drug Administration (FDA) reports that the affected devices may experience the following issues:
- Intermittent reboots lasting 5–10 seconds, during which therapy is paused, the screen goes blank, and a single audible alert sounds. The device may then restart using either the previous patient settings or factory default settings.
- Complete shutdown into a “Ventilator Inoperative” state, which stops therapy and triggers both audible and visual alarms. This can occur after three reboots within a 24-hour period or without any prior reboots.
These malfunctions can lead to serious health consequences such as therapy loss or interruption, potentially resulting in hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death, particularly in high-risk patients.
So far, the FDA has received reports of 13 injuries and eight deaths related to these issues.
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