FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 1950910
·
Received November 19, 2010
Report
- Report Number
- 9680128-2010-00308
- Event Type
- Malfunction
- Date Received
- November 19, 2010
- Date of Event
- October 20, 2010
- Report Date
- October 20, 2010
- Manufacturer
- STRYKER MEDICAL QUEBEC LP
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT DESCRIPTION: BED EXIT ALARM.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE BED EXIT HAD NO ALARM FUNCTION. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOBED II | HOSPITAL BED, A-C POWERED, ADJUSTABLE | FNL | STRYKER MEDICAL QUEBEC LP | FL28C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |