FDA Adverse Event
Injury
Summary report: N
INVACARE BEDS
MDR report key: 922480
·
Received October 2, 2007
Report
- Report Number
- 1525712-2007-00060
- Event Type
- Injury
- Date Received
- October 2, 2007
- Date of Event
- August 29, 2007
- Report Date
- September 26, 2007
- Manufacturer
- INVACARE BEDS
- Product Code
- FNJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE DEALER ALLEGES SMOKE WAS COMING OUT OF WHERE THE WIRES ARE ON THE BED. NO DETAILS ON THE ALLEGED INJURIES WERE AVAILABLE OTHER THAN ONE PATIENT WAS ADMITTED TO THE HOSPITAL FROM THE SMOKE SMELL. IT'S UNCLEAR IF WIRES HAD BECOME ENTRAPPED. IN ADDITION, THE POTTING MATERIAL THAT ENCAPSULATES THE PCB ASSEMBLY, AND THE CASE BODY ARE PRODUCED FROM FLAME RATED MATERIALS.
Description of Event or Problem · 1
THE DEALER ALLEGES SMOKE WAS COMING OUT OF WHERE THE WIRES ARE ON THE BED. ALLEGED INJURIES ARE NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE BEDS | 880.5100 | FNJ | INVACARE BEDS | BAR600IVC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |