BiPAP V30 Auto Ventilator May Interrupt Therapy During Malfunction Alarm
Philips BiPAP V30 Auto Ventilators may interrupt or lose therapy during a Ventilator Inoperative alarm, potentially causing hypoventilation, severe oxygen depletion, or respiratory failure.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The hazard directly threatens patient safety with risk of respiratory failure and potential death in vulnerable patients affecting a life-critical medical device.
Plain-English summary
Philips Respironics is recalling BiPAP V30 Auto Ventilators (Part Number 1111178) due to a potential defect that can cause devices to interrupt or lose therapy during a Ventilator Inoperative alarm condition.
When therapy is interrupted, patients may experience hypoventilation, mild to severe hypoxemia (low blood oxygen levels), hypercarbia (elevated carbon dioxide levels), respiratory failure, respiratory insufficiency, or in the most vulnerable patients, potentially death.
Approximately 5,958 units have been distributed in the United States. The affected ventilators have been distributed worldwide, including across the United States, Puerto Rico, Guam, and various European countries.
Patients currently using the affected ventilators should contact their healthcare provider or Philips Respironics immediately. Healthcare providers and patients should monitor for any unusual device behavior or alarm conditions and follow manufacturer guidance regarding this recall.
The recalled product
- Product
- BiPAP V30 Auto Ventilator, Part Number 1111178
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 5,958
Distribution
Part of a larger recall action
This product is one of 3 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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