FDA Adverse Event
Death
Summary report: N
BIPAP AUTOSV ADV
MDR report key: 18485959
·
Received January 10, 2024
Report
- Report Number
- 2518422-2024-00621
- Event Type
- Death
- Date Received
- January 10, 2024
- Date of Event
- June 18, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNS
- UDI-DI
- 00606959012516
- PMA / PMN Number
- K090539
- Removal / Correction Number
- Z-1973-2021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 0
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE PATIENT PASSED AWAY. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2552574 | BIPAP AUTOSV ADV | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | MNS | RESPIRONICS, INC. | DS960S | 00606959012516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |