FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 2223174
·
Received August 16, 2011
Report
- Report Number
- 1831750-2011-08669
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 18, 2011
- Report Date
- July 18, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE RIGHT SIDE RAIL WOULD NOT LATCH UP. THE RIGHT TOPRAIL WAS ALSO BROKEN AND THERE WERE SHARP EDGES. NO PT INVOLVEMENT OR 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 |