FDA Adverse Event
Malfunction
Summary report: N
INCUBATOR
MDR report key: 11690
·
Received February 18, 1994
Report
- Report Number
- MW1000851
- Event Type
- Malfunction
- Date Received
- February 18, 1994
- Manufacturer
- AIR-SHIELDS VICKERS, INC.
- Product Code
- FMZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- LA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
DEVICE WAS NOT HEATING PROPERLY. THEN HI-OUTPUT TRANSISTOR SOCKET HAD MELTED WHEN TRANSISTOR OVERHEATED (SHORTED). NO INJURY TO PT. UNIT WAS NOT BEING USED WITH PT. IT WAS WARMING UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INCUBATOR | FMZ | AIR-SHIELDS VICKERS, INC. | C-300-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |