FDA Adverse Event
Malfunction
Summary report: N
EPIC II CRITICAL CARE BED
MDR report key: 3230286
·
Received July 16, 2013
Report
- Report Number
- 0001831750-2013-06415
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Date of Event
- June 24, 2013
- Report Date
- June 24, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOT END OF BED WAS STUCK IN FULL UP POSITION AND WONT LOWER DUE TO CPU BOARD MALFUNCTIONED. 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 |
|---|---|---|---|---|---|---|---|
| 328635 | EPIC II CRITICAL CARE BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |