FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 26
MDR report key: 2873786
·
Received November 14, 2012
Report
- Report Number
- 1831750-2012-11841
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 16, 2012
- Report Date
- October 16, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES COULD NOT HOLD AND THE SIDE RAIL COULD BECOME UNLATCHED DUE TO MISSING COMPRESSION SPRINGS. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RENAISSANCE 26 | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |