FDA Adverse Event
Malfunction
Summary report: N
PHILLIPS DREAMSTATION
MDR report key: 12861594
·
Received November 22, 2021
Report
- Report Number
- MW5105521
- Event Type
- Malfunction
- Date Received
- November 22, 2021
- Report Date
- November 18, 2021
- Manufacturer
- PHILIPS / RESPIRONICS, INC.
- Product Code
- BZD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
WAS TOLD THAT MY DREAMSTATION CPAP HAS BEEN RECALLED. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1755792 | PHILLIPS DREAMSTATION | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | PHILIPS / RESPIRONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Male |