FDA Adverse Event
Malfunction
Summary report: N
EPIC II CRITICAL CARE BED
MDR report key: 2223318
·
Received August 17, 2011
Report
- Report Number
- 1831750-2011-08801
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 21, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EC
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: THE DISTRIBUTOR HAS BEEN SENT PARTS AND WILL COMPLETE THE REPAIR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BED WAS STUCK IN AN ELEVATED POSITION. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE 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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |