FDA Adverse Event
Death
Summary report: N
BIPAP AUTOSV ADV
MDR report key: 19279168
·
Received May 9, 2024
Report
- Report Number
- 2518422-2024-26540
- Event Type
- Death
- Date Received
- May 9, 2024
- Date of Event
- November 10, 2022
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNS
- UDI-DI
- 00606959031968
- PMA / PMN Number
- K090248
- Removal / Correction Number
- Z-1972-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 A PATIENT WITH A BIPAP AUTOSV ADV DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1383909 | BIPAP AUTOSV ADV | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | MNS | RESPIRONICS, INC. | 960P | 00606959031968 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |