FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 2061845
·
Received March 18, 2011
Report
- Report Number
- 1831750-2011-02592
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 22, 2011
- Report Date
- February 22, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Removal / Correction Number
- Z-228-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WILL NOT HOLD. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM204 M-SERIES W/BIG WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |