BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2971921 · Received February 21, 2013

    Report

    Report Number
    0001831750-2013-01402
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS PREVIOUSLY REPORTED THAT THE BRAKES COULD NOT BE ENGAGED. UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, IT WAS DETERMINED THAT ONLY ONE BRAKE PEDAL WAS UNABLE TO ENGAGE THE BRAKES, BUT THE BRAKES COULD STILL BE ENGAGED USING AN ALTERNATIVE PEDAL.

    Additional Manufacturer Narrative · 1

    BARE WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE CUSTOMER ALLEGED THAT THE HEAD END BRAKES DO NOT ENGAGE. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT THE HEAD END BRAKES COULD NOT ENGAGE AND THE POWER CORD WAS FRAYED WITH ELECTRICAL WIRES EXPOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE CUSTOMER ALLEGED THAT THE HEAD END BRAKES DO NOT ENGAGE. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT THE HEAD END BRAKES COULD NOT ENGAGE AND THE POWER CORD WAS FRAYED WITH ELECTRICAL WIRES EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75920 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO 1025

    Patients

    Seq Age Sex Outcome Treatment
    1