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Philips changes instructions for use of BiPAPs linked to 65 deaths

Posted on by darion

Summary: Philips Respironics has updated the instructions for use for the BiPAP V30, A30 and A40 ventilators due to potential interruptions in therapy posing a serious health risk. 65 deaths and 952 injuries have been reported. The recall, considered the most serious by the FDA, advises users to immediately follow the new guidelines. Key actions include removing patients from the device if a ventilator failure alarm occurs and attempting a hard restart. The recall does not include removing the devices from where they are used or sold, but emphasizes the importance of compliance to avoid injury or death.

Key conclusions:

  • Philips Respironics has updated the instructions for use of the BiPAP V30, A30 and A40 ventilators due to the potential for therapy interruptions that could lead to serious injury or death. 65 deaths and 952 injuries were reported.
  • A product recall is an update to a device’s instructions for use without necessarily removing the device from use. The FDA has deemed this the most serious type of recall.
  • Philips advises patients and caregivers to immediately follow the updated instructions, including switching to alternative ventilation if necessary and attempting a hard restart to temporarily restore device functionality.

Philips Respironics has updated the instructions for use of the BiPAP V30, A30 and A40 ventilators due to potential therapy interruptions and/or loss of therapy.

The recall includes updating the instructions for use of BiPAP V30, BiPAP A30, BiPAP A40 devices and does not involve removing them from the place where they are used or sold. The US Food and Drug Administration (FDA) has classified this recall as the most serious type. According to the recall notice issued by the FDA, this device may cause serious injury or death if continued use without following updated instructions.

There were 952 reported injuries. There were 65 reports of deaths.

Affected product

  • Product names: BiPAP V30, BiPAP A30, BiPAP A40
  • Unique device identifier/model:
    • 00606959049635/BiPAP V30 Automatic
    • 00606959039308/BiPAP A30
    • 00606959039476/BiPAP A40
  • Lot/serial numbers:

What to do

On March 26, Philips Respironics sent an emergency medical device recall notice to all customers, recommending the following actions:

  • If a ventilator failure alarm occurs, immediately disconnect the patient from the device and connect them to an alternative source of ventilation, if available.
    • Optionally, you can attempt to perform a “hard reboot” (force restart the device), which may temporarily restore operation of the device.
  • Identify your customer list and, as appropriate, forward this Urgent Medical Device Recall Notice and all applicable attachments to physicians, clinicians, patients and/or users.
  • Complete and return the response form included in this notice.

Reason for updating the user manual

Philips Respironics is updating the instructions for use of the V30, A30 and A40 ventilators due to a failure of the ventilator down alarm which may result in interruption or loss of therapy.

The device can:

  • Restart the computer intermittently for 5-10 seconds (therapy stop, blank screen, single beep), then restart with the same patient settings.
  • Restart intermittently for 5-10 seconds (therapy stop, blank screen, single beep), then restart with factory default settings.
  • Enter a ventilator disabled state (therapy stopped, audible and visual alarms on) after three restarts within 24 hours or without prior restart.

These problems may result in interruption or loss of therapy, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in susceptible patients. 952 injuries were reported. 65 deaths were reported.

Device use

The BiPAP V30 Auto ventilator provides noninvasive support for adults and children weighing more than 10 kg (22 lbs) with obstructive sleep apnea (OSA) and respiratory failure. It is intended for use in institutions or hospitals and is not intended to support life, but can be used during transport within a facility.

The BiPAP A30 ventilator provides noninvasive support for adults and children weighing more than 10 kg (22 lbs) with OSA and respiratory failure. It is suitable for home use and clinical settings such as hospitals, sleep laboratories and intermediate care facilities.

The BiPAP A40 Pro ventilator provides invasive and non-invasive support for adults and children weighing over 10 kg (22 lb) with OSA, respiratory distress or respiratory distress. It is not intended for life support or transportation, but is intended for home and clinical use, including portable applications such as wheelchairs and stretchers.

Customers in the United States with questions regarding this recall should contact Philips Respironics at 1-800-345-6443, prompts 4 or 5, or email (email protected).