FDA Adverse Event
Malfunction
Summary report: N
BIPAP A40
MDR report key: 18255514
·
Received December 4, 2023
Report
- Report Number
- 2518422-2023-33255
- Event Type
- Malfunction
- Date Received
- December 4, 2023
- Date of Event
- August 16, 2017
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNT
- PMA / PMN Number
- K121623
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURE FOR EVALUATION AND THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE FOLLOWING REPORTABLE ERROR CODES WERE LOGGED IN THE ERROR LOG: 68, 101, 103, 104, 177, 204. THE MAIN PCA WAS REPLACED. LIFE RELATED SMELL WAS CONFIRMED SO THE OUTLET FLOW PATHS WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1592458 | BIPAP A40 | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | MNT | RESPIRONICS, INC. | R1111177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |