FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 26 P-WASS 10/04
MDR report key: 2954827
·
Received February 11, 2013
Report
- Report Number
- 0001831750-2013-00964
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 19, 2013
- Report Date
- January 19, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE STRETCHER WAS BROKEN. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT THE BRAKES COULD NOT BE FULLY ENGAGED DUE TO A BROKEN BRAKE CAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58834 | RENAISSANCE 26 P-WASS 10/04 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 1231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |