FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 3041518
·
Received April 8, 2013
Report
- Report Number
- 0001831750-2013-03015
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 11, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD END JACK WAS STUCK RAISED AND COULD NOT LOWER DUE TO RELEASE LINKAGE DETACHING FROM BASE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142799 | SM304 M-SERIES W/ZOOM | STRETCHER, WHEELED, POWERED | INK | STRYKER MEDICAL-KALAMAZOO | 1025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |