FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 1882600
·
Received October 22, 2010
Report
- Report Number
- 1831750-2010-03156
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 23, 2010
- Report Date
- September 23, 2010
- Manufacturer
- STRYKER CORP, MEDICAL DIVISION
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE PEDALS FOR LOWERING THE HEAD LIFT ARE STICKING. THE HEAD END WOULD NOT STAY UP, IT WAS DRIFTING DOWN. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM304 M-SERIES W/ZOOM | WHEELED POWERED STRETCHER | INK | STRYKER CORP, MEDICAL DIVISION | 1025 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |