FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 3023722
·
Received March 27, 2013
Report
- Report Number
- 0001831750-2013-02605
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- February 28, 2013
- Report Date
- February 28, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE INOPERABLE DUE TO MALFUNCTIONED BRAKE CAMS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126073 | SM204 M-SERIES W/BIG WHEEL | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 1015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |