FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 2010193
·
Received March 1, 2011
Report
- Report Number
- 1831750-2011-02019
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 1, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE UNIT'S HEAD END LIFT HYDRAULICS COULD NOT BE PUMPED ALL OF THE WAY UP AND WERE SLOWLY DRIFTING BACK DOWN. 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 MEDICAL | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |