FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 3081127
·
Received April 26, 2013
Report
- Report Number
- 0001831750-2013-03800
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 5, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BED EXIT WAS NOT FUNCTIONAL AS THE SCALE WAS NOT ZEROED. IT WAS ALSO REPORTED THAT THE NURSE CALL CABLE WAS MISSING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182260 | GOBED II | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |