FDA Adverse Event
Malfunction
Summary report: N
BIPAP A40 PRO
MDR report key: 18301239
·
Received December 11, 2023
Report
- Report Number
- 2518422-2023-34648
- Event Type
- Malfunction
- Date Received
- December 11, 2023
- Date of Event
- July 11, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNT
- UDI-DI
- 00606959055063
- PMA / PMN Number
- K121623
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR SERIOUS INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO (GBX3100S19) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, K121623.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2136514 | BIPAP A40 PRO | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS, INC. | GBX3100S19 | 00606959055063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |