BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 2971917 · Received February 21, 2013

    Report

    Report Number
    0001831750-2013-01406
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAKE CAMS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE CUSTOMER ALLEGED THAT THE BRAKES WERE NOT ENGAGING. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS CONFIRMED THAT THE BRAKES WOULD NOT STAY ENGAGED DUE TO MALFUNCTIONED BRAKE CAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76376 SM204 M-SERIES W/BIG WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1015

    Patients

    Seq Age Sex Outcome Treatment
    1