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Philips Updates BiPAP Ventilator Use Instructions

David McFarland

— 1 min read
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Philips Respironics has issued updated instructions for three of its BiPAP ventilators due to interruptions and/or loss of therapy. An FDA notice says the recall does not involve removing the devices from where they are used or sold. It is considered a Class 1 recall, the notice says, because the devices may cause serious injury or death if they are used without following the updated instructions.

The notice says Philips updated the use instructions due to a failure in the ventilator inoperative alarm, which can cause therapy interruption or loss. It says the device may:

  • reboot intermittently for five to 10 seconds and then restart with the same patient settings;
  • reboot intermittently for five to 10 seconds and then restart with factory default settings; or
  • enter a ventilator inoperative state after three reboots within 24 hours or without a preceding reboot.

“These issues can result in therapy interruption or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients,” FDA says. It says there have been 952 reported injuries and 65 reports of death.

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