FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 3092229
·
Received May 3, 2013
Report
- Report Number
- 0001831750-2013-04065
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 12, 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 SCALE WAS INACCURATE DUE TO LOAD CELL MALFUNCTION. 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 |
|---|---|---|---|---|---|---|---|
| 194097 | GOBED II | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |