FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 1925524
·
Received November 23, 2010
Report
- Report Number
- 1831750-2010-04155
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 27, 2010
- Manufacturer
- STRYKER CORP, MEDICAL DIV
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE STRETCHER LEFT SIDE RAIL SPINDLE WAS BROKEN IN HALF. IT WAS ALSO REPORTED THAT THE SIDE RAIL WAS BEING SLAMMED UP. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM304 M-SERIES W/ZOOM | STRETCHER, WHEELED, POWERED | INK | STRYKER CORP, MEDICAL DIV | 1025 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |