FDA Adverse Event
Malfunction
Summary report: N
EPIC II CRITICAL CARE BED
MDR report key: 1974606
·
Received December 29, 2010
Report
- Report Number
- 1831750-2010-05286
- Event Type
- Malfunction
- Date Received
- December 29, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 1, 2010
- Manufacturer
- STRYKER CORP, MEDICAL DIVISION
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
SIDERAIL.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD LEFT SIDERAIL WILL NOT STAY IN THE FULL UPWARD POSITION. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
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 DIVISION | 2030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |