BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGISTOOL

    MDR report key: 2121990 · Received June 2, 2011

    Report

    Report Number
    1831750-2011-05433
    Event Type
    Other
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SVC REPORT THAT THE BRAKES ARE NOT WORKING. AN EMPLOYEE OF THE FACILITY REPAIRED IT PRIOR TO THE SVC TECH ARRIVING TO EVALUATE AND REPAIR THE STOOL. IT WAS REPORTED THAT THE USER FACILITY EMPLOYEE HAD REPLACED THE BRAKE ASSEMBLY AND PUT THE SEAT ON BACKWARDS. IT WAS FURTHER REPORTED THAT ONE OF THE DOCTORS SAT ON THE STOOL, PUSHED BACKWARDS AND FELL OFF THE CHAIR WHEN THE BRAKE DID NOT HOLD. NO INJURIES HAVE BEEN REPORTED. THERE WAS PT INVOLVEMENT; HOWEVER, THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISTOOL STOOL, OPERATING-ROOM FZM STRYKER MEDICAL 0830 NA

    Patients

    Seq Age Sex Outcome Treatment
    1