Recall Z-1814-2024 ยท MNS Ventilator, Continuous, Non-Life-Supporting
Philips Respironics, Inc.
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
| Date | May 24, 2024 (initiated Mar 26, 2024) |
| Status | Open, Classified |
| Reason | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients. |
| Root cause | Device Design |
| Action | The firm notified customers via mailed URGENT Medical Device Recall notice on March 26, 2024. The notice described the product, problem and actions to be taken. The firm reminded customers to refer to the user manual and to perform a clinical assessment prior to placing a patient on the ventilator to ensure that: 1. The device is appropriately set for patient requirements. 2. Alternate ventilation equipment is available. 3. Alternative monitoring (such as alarming Pulse Oximeter or Respiratory) is used where appropriate. Depending on the level of ventilatory support required, customers were |
| Quantity | 3 US; 21,414 OUS |
| Distribution | Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.