FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 2935760
·
Received January 2, 2013
Report
- Report Number
- 1831750-2012-13417
- Event Type
- Malfunction
- Date Received
- January 2, 2013
- Date of Event
- December 5, 2012
- Report Date
- December 5, 2012
- Manufacturer
- FLEXTRONICS EMS CANADA
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CPR SET SCREW OUT-OF-ADJUSTMENT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE NONE OF THE BED FUNCTIONS ARE WORKING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1574 | GOBED II | A/C HOSPITAL BED | FNL | FLEXTRONICS EMS CANADA | FL28EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |