FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 3024041
·
Received March 27, 2013
Report
- Report Number
- 0001831750-2013-02621
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- February 25, 2013
- Report Date
- February 25, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE CPR DROP WAS USED, THE SIDERAIL CONTROLS WOULD NOT ENGAGE UNTIL FOWLER WAS LIFTED UP AND RESET. 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 |
|---|---|---|---|---|---|---|---|
| 127157 | GOBED II | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |