FDA Adverse Event
Malfunction
Summary report: N
INVACARE FULL/SEMI ELECTRIC HOME CARE BED
MDR report key: 45361
·
Received October 23, 1996
Report
- Report Number
- 1525712-1996-00020
- Event Type
- Malfunction
- Date Received
- October 23, 1996
- Date of Event
- September 19, 1995
- Report Date
- April 8, 1996
- Manufacturer
- INVACARE CORPORATION
- Product Code
- FNL
- Removal / Correction Number
- 21 USC 360
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
MFR RECEIVED A FIRE INVESTIGATION REPORT INDICATING THAT A BED MOTOR CAUSED A FIRE. REPORTED INJURY IS NOT SERIOUS AS DEFINED IN THE REGULATION. THE MOTOR WAS NOT AVAILABLE FOR EVALUATION BY THE MFR AND SUBSEQUENT REPORTS INDICATE THE MOTOR HAS BEEN DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE FULL/SEMI ELECTRIC HOME CARE BED | AC POWERED ADJ. HOSPITAL BED | FNL | INVACARE CORPORATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |