FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 1962959
·
Received December 22, 2010
Report
- Report Number
- 1831750-2010-05113
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 24, 2010
- Report Date
- November 24, 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 IN A SERVICE REPORT THE LEFT SIDERAIL WILL NOT LATCH IN THE UP POSITION. THE CUSTOMER WAS UNABLE TO DETERMINE IF THERE WAS PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.
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 |