FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 1964016
·
Received January 12, 2011
Report
- Report Number
- 1831750-2011-00365
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 15, 2010
- Report Date
- December 15, 2010
- Manufacturer
- STRYKER CORP, MEDICAL DIV
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER WAS STUCK AND WOULD NOT RAISE AND OR LOWER. THE FOWLER WOULD NOT RAISE AND OR LOWER WHEN TRYING TO USE ONE OR BOTH HANDLES. THERE WAS SOME FLUID LEAKING FROM THE CYLINDER ONTO THE STRETCHER SHROUD. ALSO, THE HEAD END JACK WAS DRIFTING. IT IS UNK IF THERE WAS PT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM204 M-SERIES W/BIG WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP, MEDICAL DIV | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |