FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 2140841
·
Received May 31, 2011
Report
- Report Number
- 1831750-2011-05308
- Event Type
- Malfunction
- Date Received
- May 31, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 3, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVAL: HANDLE WELMENT; LOADCELL MOUNT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE LED ON THE HANDLES WERE INTERMITTENT AND THERE WERE SHARP EDGES EXPOSED ON THE BROKEN HEAD END PLASTIC COVER. NO PT 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 MEDICAL | 1025 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |