FDA Adverse Event
Malfunction
Summary report: N
EPIC II CRITICAL CARE BED
MDR report key: 1983661
·
Received January 31, 2011
Report
- Report Number
- 1831750-2011-00908
- Event Type
- Malfunction
- Date Received
- January 31, 2011
- Date of Event
- December 30, 2010
- Report Date
- January 4, 2011
- Manufacturer
- STRYKER CORP., MEDICAL DIVISION
- Product Code
- FNL
- Removal / Correction Number
- Z-2586-2010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WELDMENT TUBE AND BALL SCREW COVER. ADDITIONAL INFO IS NEEDED IN ORDER TO REPAIR THE BED; HOWEVER, THE UNIT WILL BE REPAIRED.
Description of Event or Problem · 1
TECHNICAL SERVICE VISITED THE HOSPITAL BECAUSE OUR CUSTOMER HAD REPORTED PROBLEMS WITH 2 BEDS. THE PROBLEMS FOUND WERE: CPR MECHANISM CRASHED (WITHOUT WORKING). FOWLER SYSTEM IS NOT WORKING PROPERLY (ELEVATION IS NOT POSSIBLE IN A CONTINUOUS WAY). ACCORDING TO OUR TECHNICAL SUPPORT TECHNICIAN, THE PROBLEM WAS THAT THE WELDMENT TUBE WAS BROKEN AS WELL AS THE BALL SCREW COVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC II CRITICAL CARE BED | AC POWER HOSPITAL BED | FNL | STRYKER CORP., MEDICAL DIVISION | 2030 EPIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |