FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 3061509
·
Received April 16, 2013
Report
- Report Number
- 0001831750-2013-03353
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 25, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 DAMAGED LOAD CELLS. 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 |
|---|---|---|---|---|---|---|---|
| 162159 | GOBED II | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |