FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 26 STRETCHR 11/00
MDR report key: 3032571
·
Received April 3, 2013
Report
- Report Number
- 0001831750-2013-02848
- Event Type
- Malfunction
- Date Received
- April 3, 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 BY REPAIR WORK ORDER THAT THE BRAKES COULD NOT BE ENGAGED FROM THE HEAD END DUE TO A BROKEN BRAKE ADJUSTER. HOWEVER, THE BRAKES COULD STILL BE ENGAGED FROM THE FOOT END. 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 |
|---|---|---|---|---|---|---|---|
| 136554 | RENAISSANCE 26 STRETCHR 11/00 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 1211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |