FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 3250760
·
Received July 29, 2013
Report
- Report Number
- 0001831750-2013-06739
- Event Type
- Malfunction
- Date Received
- July 29, 2013
- Date of Event
- July 2, 2013
- Report Date
- July 2, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUPPLEMENTAL SUBMITTED AS THE INVESTIGATION CONCLUDED THAT THE NURSE CALL CABLE WAS DAMAGED.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE NURSE CALL CABLE WAS DAMAGED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE NURSE CALL CABLE WAS MISSING. 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 |
|---|---|---|---|---|---|---|---|
| 352389 | GOBED II | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |