FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 2910117
·
Received December 19, 2012
Report
- Report Number
- 1831750-2012-13028
- Event Type
- Malfunction
- Date Received
- December 19, 2012
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- FLEXTRONICS EMS CANADA
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER MOTOR FAILED. CPR MANUAL RELEASE WAS NOT FUNCTIONAL AND THE FOWLER COULD NOT BE LOWERED TO ITS LOWEST HEIGHT. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOBED II | A/C HOSPITAL BED | FNL | FLEXTRONICS EMS CANADA | FL28EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |