FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 2864645
·
Received November 9, 2012
Report
- Report Number
- 1831750-2012-11772
- Event Type
- Malfunction
- Date Received
- November 9, 2012
- Date of Event
- October 10, 2012
- Report Date
- October 16, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TUBE TWISTED.
Description of Event or Problem · 1
IT WAS REPORTED BY OUR TECH THAT THE BED SHOW ISSUES WITH THE FOWLER SYSTEM. THE HEAD TUBE IS TWISTED AND IT'S BLOCKING THE ELEVATION OF THE FOWLER. ACCORDING TO OUR TECH, THE FAILURE APPEARS WHEN THE ELEVATION AND DESCENDING SYSTEM IS ACTIVATED IN A MANUALLY WAY.
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 |