FDA Adverse Event
Malfunction
Summary report: N
GO BED PLUS
MDR report key: 2991411
·
Received March 6, 2013
Report
- Report Number
- 0001831750-2013-01805
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 12, 2013
- Report Date
- February 12, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SCALE WAS INCORRECT DUE TO MALFUNCTIONED 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 |
|---|---|---|---|---|---|---|---|
| 94958 | GO BED PLUS | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |