FDA Adverse Event
Malfunction
Summary report: N
PRIME 5TH WHEEL STRETCHER, 26"
MDR report key: 3031094
·
Received April 2, 2013
Report
- Report Number
- 0001831750-2013-02788
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 5, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WOULD NOT ENGAGE DUE TO PINS MISSING CAUSING THE BRAKE PEDAL TO BE OUT OF ALIGNMENT. 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 |
|---|---|---|---|---|---|---|---|
| 133488 | PRIME 5TH WHEEL STRETCHER, 26" | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |