FDA Adverse Event
Malfunction
Summary report: N
EPIC II CRITICAL CARE BED
MDR report key: 1974085
·
Received December 28, 2010
Report
- Report Number
- 1831750-2010-05244
- Event Type
- Malfunction
- Date Received
- December 28, 2010
- Date of Event
- November 30, 2010
- Report Date
- November 30, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: SIDERAIL PANEL. HEADBOARD AND FOOTBOARD.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED HAS CRACKED INNER AND OUTER PANELS AS WELL AS CRACKED FOOT AND HEAD BOARDS. NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC II CRITICAL CARE BED | A/C POWERED HOSPITAL BED | FNL | STRYKER CORP., MEDICAL DIV. | 2030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |