FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 1894721
·
Received November 4, 2010
Report
- Report Number
- 1831750-2010-03528
- Event Type
- Malfunction
- Date Received
- November 4, 2010
- Date of Event
- October 8, 2010
- Report Date
- October 8, 2010
- Manufacturer
- STRYKER CORP, MEDICAL DIVISION
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE LEFT SIDERAIL LATCH DOES NOT WORK. THE USER FACILITY WAS UNABLE TO PROVIDE ANY INFO AS TO WHETHER THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCE ASSOCIATED WITH THE REPORTED ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM304 M-SERIES W/ZOOM | WHEELED POWERED STRETCHER | INK | STRYKER CORP, MEDICAL DIVISION | 1025 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |