FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 2913989
·
Received January 14, 2013
Report
- Report Number
- 0001831750-2013-00067
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 21, 2012
- Report Date
- December 21, 2012
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): ZOOM; HANDLES.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM WAS INTERMITTENT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM WAS INTERMITTENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20376 | SM304 M-SERIES W/ZOOM | STRETCHER, WHEELED, POWERED | INK | STRYKER MEDICAL-KALAMAZOO | 1025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |