FDA Adverse Event
Malfunction
Summary report: N
PRIME 5TH WHEEL STRETCHER, 26"
MDR report key: 3040605
·
Received April 8, 2013
Report
- Report Number
- 0001831750-2013-02990
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 15, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WOULD NOT ENGAGE DUE BOTH HEAD AND FOOT END BRAKE PEDALS BEING DISCONNECTED FROM THE BRAKE ROD. ADDITIONALLY, THE MATTRESS COULD NOT ADHERE TO THE LITTER SURFACE DUE TO THE VELCRO PILES MISSING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143674 | PRIME 5TH WHEEL STRETCHER, 26" | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 1105000026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |