FDA Adverse Event
Malfunction
Summary report: N
GOBED II MED/SURG BED
MDR report key: 2964294
·
Received February 15, 2013
Report
- Report Number
- 0001831750-2013-01235
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 21, 2013
- Report Date
- January 21, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: INITIAL EVALUATION WAS VISUAL ONLY; SECOND EVALUATION REQUIRED TO DETERMINE EXACT CAUSE. CONCLUSION: UPON REPAIR OF DEVICE, A SUPPLEMENTAL REPORT WILL BE FILED IF APPROPRIATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FOWLER WOULD NOT LAY BELOW 15 DEGREES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67410 | GOBED II MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |