FDA Adverse Event
Other
Summary report: N
DREAM STATION 2
MDR report key: 20823126
·
Received November 29, 2024
Report
- Report Number
- MW5163044
- Event Type
- Other
- Date Received
- November 29, 2024
- Date of Event
- November 23, 2024
- Report Date
- November 25, 2024
- Manufacturer
- PHILLIPS/RESPIRONICS INC.
- Product Code
- BZD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
MY CPAP MACHINE A PHILLIPS DREAMSTATION 2 OVERHEATED BECAME HOT WITH A BURNING SMELL WHILE PLUGGED IN BUT NOT TURNED ON HAD TO REMOVE AND DISCARD THE MACHINE FOR POTENTIAL FIRE HAZARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1682134 | DREAM STATION 2 | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | PHILLIPS/RESPIRONICS INC. | DSX520H11C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Other |