FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 2050681
·
Received March 14, 2011
Report
- Report Number
- 1831750-2011-02460
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- February 15, 2011
- Report Date
- February 15, 2011
- Manufacturer
- STRYKER MEDICAL
- 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 PT LEFT SIDE RAIL HANDLE WAS BROKEN AND WOULD NOT LATCH IN THE UPRIGHT POSITION. 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 |