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
Recall
- Recall Number
- Z-1814-2024
- Event Number
- 94475
- Firm
- Philips Respironics, Inc.
- FEI Number
- 2518422
- Product Code
- MNS
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- March 26, 2024
- Posted
- May 24, 2024
- Address
- 1001 Murry Ridge Ln, Murrysville, PA, 15668-8517
Description
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
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.
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 advised to place patients on an alternate source of ventilation. Philips is currently investigating the issue. If you need any further information or support concerning this issue, please contact your local Philips Respironics representative: 1-800-345-6443, prompts 4, 5 or email at [email protected]. A second "URGENT Medical Device Recall" notice was distributed to customers on June 12, 2024. In the notice customers were provided additional guidance on how to operate the device when a Ventilator Inoperative Alarm occurs and how to perform an optional hard reboot of their device that will temporarily restore functionality. A third "URGENT Medical Device Recall" notice was distributed to customers on October 4, 2024. In the notice customers are informed of the updated intended use indications for affected devices and when use of devices is appropriate.
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.
3 US; 21,414 OUS