FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 26 P-WASS
MDR report key: 2012848
·
Received March 3, 2011
Report
- Report Number
- 1831750-2011-02127
- Event Type
- Malfunction
- Date Received
- March 3, 2011
- Date of Event
- February 4, 2011
- Report Date
- February 4, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Removal / Correction Number
- Z-234-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
EVAL: DRIVE LINK ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE NOT HOLDING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
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 | NA |