FDA Adverse Event
Death
Summary report: N
BIPAP AUTOSV ADV
MDR report key: 19551463
·
Received June 17, 2024
Report
- Report Number
- 2518422-2024-37238
- Event Type
- Death
- Date Received
- June 17, 2024
- Date of Event
- October 9, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNS
- PMA / PMN Number
- K090539
- Removal / Correction Number
- Z-1973-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
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 EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, DIZZINESS AND/OR HEADACHE, NAUSEA/VOMITING, ASTHMA (NEW OR WORSENING), LUNG DISEASE. THERE WAS A REPORT OF PATIENT DEATH. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2338135 | BIPAP AUTOSV ADV | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | MNS | RESPIRONICS, INC. | DS950HS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |