FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 2191391
·
Received July 28, 2011
Report
- Report Number
- 1831750-2011-07802
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- June 30, 2011
- Report Date
- June 30, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE RIGHT SIDERAIL COULD NOT LATCH UP AND THE RIGHT TOPRAIL WAS BROKEN AT THE END EXPOSING SHARP EDGES. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM304 M-SERIES W/ZOOM | WHEELED POWERED STRETCHER | INK | STRYKER MEDICAL | 1025 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |