FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 26 P-WASS
MDR report key: 2933596
·
Received December 21, 2012
Report
- Report Number
- 1831750-2012-13324
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 27, 2012
- Report Date
- November 27, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES COULD NOT BE ENGAGED. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RENAISSANCE 26 P-WASS | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1231 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |