FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 1941164
·
Received December 8, 2010
Report
- Report Number
- 1831750-2010-04622
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- November 11, 2010
- Report Date
- November 11, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIVISION
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: LOAD CELL, PCB BOX.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM DRIVE ON STRETCHER WOULD SEEM TO STOP AND START WHILE USING THE STRETCHER. NO PATIENT 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 CORP., MEDICAL DIVISION | 1025 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |