FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 1932772
·
Received November 30, 2010
Report
- Report Number
- 1831750-2010-04291
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Date of Event
- November 3, 2010
- Report Date
- November 3, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- 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 BRAKES ARE NOT WORKING. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM304 M-SERIES W/ZOOM | STRETCHER, WHEELED, POWERED | INK | STRYKER CORP., MEDICAL DIV. | 1025 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |