FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 2120064
·
Received May 26, 2011
Report
- Report Number
- 1831750-2011-05158
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 1, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FAILED NUT IN LIFT MOTOR. LOSS OF SCALE CALIBRATION.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE ANGLE VALUES ON THE BED ARE NOT ACCURATE AND THAT LIFT HI-LO LIFT MOTOR IS DRIFTING. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOBED II | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | FL28EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |