FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 2133875
·
Received May 12, 2011
Report
- Report Number
- 1831750-2011-04594
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULT: BRAKE CAM.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER BRAKES DO NOT STAY LOCKED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM204 M-SERIES W/BIG WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |