BiPAP A30 Ventilator Recall: Risk of Therapy Interruption and Respiratory Failure
Philips Respironics BiPAP A30 Ventilators may experience interruption or loss of therapy during a Ventilator Inoperative alarm, potentially causing severe respiratory compromise or death in vulnerable patients.
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 medical device recall for a life-support ventilator with potential therapy interruption leading directly to respiratory failure, hypoxemia, and potentially death in vulnerable patients. FDA Class I classification mandates a minimum severity score of 4.
Plain-English summary
Philips Respironics, Inc. is recalling certain BiPAP A30 Ventilators (Part Number 1111143 and related international part numbers) due to a potential safety defect.
The devices may experience interruption or loss of therapy delivery during a Ventilator Inoperative alarm condition. When therapy is interrupted, patients may experience hypoventilation, hypoxemia, hypercarbia, or respiratory failure and insufficiency. In the most vulnerable patients, this interruption could potentially lead to death.
The recall affects approximately 3 units distributed in the United States, Puerto Rico, and Guam, and approximately 21,414 units distributed internationally across Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.
Patients and healthcare providers using affected BiPAP A30 Ventilators should contact Philips Respironics, Inc. immediately for instructions on device replacement or repair. Continued use of affected units poses a risk of serious respiratory compromise.
The recalled product
- Product
- BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
- Manufacturer
- Philips Respironics, Inc.
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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