FDA Adverse Event
Malfunction
Summary report: N
EPIC II CRITICAL CARE BED
MDR report key: 2212961
·
Received July 12, 2011
Report
- Report Number
- 1831750-2011-06915
- Event Type
- Malfunction
- Date Received
- July 12, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 16, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Removal / Correction Number
- Z-1686-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES ARE NOT HOLDING. NO PT INVOLVEMENT OR 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 MEDICAL | 2030 EPIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |