FDA Adverse Event
Malfunction
Summary report: N
RENAISSANCE 29 P-WASH
MDR report key: 2133873
·
Received May 12, 2011
Report
- Report Number
- 1831750-2011-04595
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULT: THE SIDE RAILS AND HYDRAULIC SYSTEMS PERFORMED ACCORDING TO SPECIFICATIONS AND NO DAMAGE OBSERVED. RESULT: BRAKE ROD.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL WAS BROKEN AND THE FOOT END OF THE BED DRIFTS DOWN WHEN IT IS PUMPED UP. THE HEAD AND FOOT END BRAKE/STEER PEDALS BROKE EXPOSING SHARP EDGES AND THE BRAKES ARE NOT ENGAGING. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RENAISSANCE 29 P-WASH | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1731 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |