FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 1874992
·
Received October 13, 2010
Report
- Report Number
- 1831750-2010-02825
- Event Type
- Malfunction
- Date Received
- October 13, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 15, 2010
- Manufacturer
- STRYKER CORP. MEDICAL DIVISION
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HYDRAULICS JACK WERE LEAKING FLUID. THE USER FACILITY WAS UNABLE TO PROVIDE ANY INFORMATION AS TO WHETHER THERE WAS PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCE ASSOCIATED WITH THE REPORTED ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM204 M-SERIES W/BIG WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP. MEDICAL DIVISION | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |