BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSI MIZUHO

    MDR report key: 1090703 · Received July 31, 2008

    Report

    Report Number
    MW5007862
    Event Type
    Malfunction
    Date Received
    July 31, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 31, 2008
    Manufacturer
    ORTHOPEDIC SYSTEMS INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WITH A PT ON THE OSI TABLE DURING A NEURO CASE, THE INDICATOR LIGHTS FOR "ROTATION SAFETY LOCK" AND THE "180 DEGREE ROTATION LOCK" LEVER WERE BOTH NOT LIGHTED. THE TABLE COULD ONLY ROTATE IN ONE DIRECTION ALTHOUGH IT SHOULD GO EITHER WAY. THE UNIT WAS TESTED OFF LINE, AND THE MOVEMENT TO THE RIGHT OR LEFT WAS AT MUCH REDUCED SPEED, AND THERE WAS A SIGNIFICANT BURNING ELECTRONIC SMELL. TILT ACTUATOR MOTOR HAS BURNED OUT AND THE CONTROL BOARD IS ALSO GONE, AS INDICATED BY THE SAFETY SWITCH BEING OFF, YET THE TABLE WILL NOT ROTATE RIGHT OR LEFT AS PER THE DESIGN FUNCTION FROM THE MANUFACTURER. THREE DAYS LATER: "FOUND OUT IS THAT WE LOST THE TILT ACTUATOR MOTOR. WHEN TESTED IT THIS MORNING, THE SPEED WAS DOWN TO ABOUT 1/3 THE NORMAL SPEED, AND THERE WAS A NOTICABLE ELECTRONIC SMELL... THE SAFETY LOCK SWITCH,... ISN'T REALLY WORKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSI MIZUHO SURGICAL TABLE FQO ORTHOPEDIC SYSTEMS INC. 5892

    Patients

    Seq Age Sex Outcome Treatment
    1