FDA Adverse Event
Malfunction
Summary report: N
PRIME BIG WHEEL STRETCHER,30"
MDR report key: 2972288
·
Received February 21, 2013
Report
- Report Number
- 0001831750-2013-01412
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 28, 2013
- Report Date
- January 28, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY REPAIR WORK ORDER THAT THE CUSTOMER ALLEGED THAT THE UNIT WAS MISSING THE FOOT LOCK LEVER. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT BOTH THE HEAD END AND FOOT END PINS HAD BEEN SHEERED IN HALF, WHICH COULD PREVENT THE BRAKES FROM BEING ENGAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76027 | PRIME BIG WHEEL STRETCHER,30" | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |