FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 2943273
·
Received February 5, 2013
Report
- Report Number
- 0001831750-2013-00715
- Event Type
- Malfunction
- Date Received
- February 5, 2013
- Date of Event
- January 11, 2013
- Report Date
- January 11, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- INK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: LOAD CELL WELDMENT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE UNIT WILL DISENGAGE OUT OF ZOOM MODE WHILE IN USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48602 | SM304 M-SERIES W/ZOOM | STRETCHER, WHEELED, POWERED | INK | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |