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Philips has reported 10 severe injuries and seven deaths linked to its A30 and A40 devices from 2011 to 2023, with no serious harm reported for V30 devices. The recall of Philips’ BiPAP machines is now associated with 952 injuries and 65 deaths, per an FDA notice.
The recall began in March due to a malfunction causing devices to shut down, but affected devices remain in use. Initially, Philips acknowledged 10 injuries and seven deaths; the reason for the recent increase is unknown.
Around 100,000 units are impacted, with faulty alarms potentially causing shutdowns. Philips advises using alternative devices if alarms occur and recommends contacting suppliers for replacements if therapy is disrupted.
Philips is investigating the issue and plans to take action. V30 machines are used in U.S. hospitals, while A30 and A40 ventilators are primarily sold outside the U.S. A consent decree restricts Philips from selling many respiratory products in the U.S.
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