FDA Adverse Event
Injury
Summary report: N
REP DREAMSTATION AUTO CPAP
MDR report key: 19703111
·
Received July 9, 2024
Report
- Report Number
- 2518422-2024-43210
- Event Type
- Injury
- Date Received
- July 9, 2024
- Date of Event
- October 9, 2023
- Report Date
- July 9, 2024
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K091319
- Removal / Correction Number
- Z-1974-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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 |
|---|---|---|---|---|---|---|---|
| 251146 | REP DREAMSTATION AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | UDSX500S11F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |