FDA Adverse Event
Malfunction
Summary report: N
GO BED 2
MDR report key: 2091209
·
Received April 20, 2011
Report
- Report Number
- 1831750-2011-03824
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- October 20, 2010
- Report Date
- October 21, 2010
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: FAILED NYLON ACME NUT IN THE HEAD END AND/OR FOOT END LIFT MOTOR ASSEMBLIES.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED WAS EXPERIENCING DRIFTING AT THE HEAD AND/OR FOOT END. THERE WERE NO ADVERSE CONSEQUENCES OR PT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GO BED 2 | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 28-0770 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |