FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 2971976
·
Received January 21, 2013
Report
- Report Number
- 1831750-2013-90514
- Event Type
- Malfunction
- Date Received
- January 21, 2013
- Date of Event
- December 26, 2012
- Report Date
- December 26, 2012
- Manufacturer
- FLEXTRONICS EMS CANADA
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE REASON FOR THE SERIALIZATION STARTING WITH (B)(4) IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BED WAS DRIFTING. THERE WAS NO PT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29129 | GOBED II | A/C HOSPITAL BED | FNL | FLEXTRONICS EMS CANADA | FL28EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |