FDA Adverse Event
Malfunction
Summary report: N
SM104 M-SERIES W/5TH WHEEL
MDR report key: 1850058
·
Received September 27, 2010
Report
- Report Number
- 1831750-2010-02583
- Event Type
- Malfunction
- Date Received
- September 27, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 2, 2010
- Manufacturer
- STRYKER CORP, MEDICAL DIVISION
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER WAS LEAKING HYDRAULIC FLUID AT THE FOOT END HYDRAULIC LIFT JACK. THE USER FACILITY WAS UNABLE TO PROVIDE ANY INFO AS TO WHETHER THERE WAS PT INVOLVEMENT. HOWEVER, IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE REPORTED ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 M-SERIES W/5TH WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP, MEDICAL DIVISION | 1007 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |