BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL, MADE FOR: PHILIPS

    MDR report key: 2764722 · Received September 21, 2012

    Report

    Report Number
    9617251-2012-00001
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    SEDECAL SA
    Product Code
    IZL
    PMA / PMN Number
    K111725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THIS EVENT IS A DISCONNECTED WIRE IN THE MOTION CONTROL ELECTRONICS.

    Description of Event or Problem · 1

    THERE WERE NO INJURIES. INJURY IS POSSIBLE IF THE EVENT WERE TO HAPPEN AGAIN. THIS EVENT INVOLVES A MOBILE X-RAY SYSTEM WITH BATTERY ASSISTED MOTION CONTROL. THE SYSTEM WAS BEING MOVED (USING MOTOR ASSIST) FORWARD AND TO THE RIGHT. WHEN THE DEAD MAN HAND SWITCH WAS RELEASED, THE UNIT SHOULD HAVE SLOWED TO A HALT WITHIN 1.5 SECONDS. INSTEAD THE SYSTEM SPEED INCREASED, MOVING TO THE RIGHT IN A CIRCLE. THE OPERATOR HAD TO QUICKLY STEP OUT OF THE WAY TO AVOID THE UNIT'S MOTION. THE UNIT STOPPED ON IT'S OWN AFTER LESS THAN 2 SECONDS. SO INSTEAD OF DECREASING SPEED AFTER THE SWITCH RELEASE, THE UNIT INCREASED SPEED UNTIL THE BRAKE ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEDECAL, MADE FOR: PHILIPS MOBILE X-RAY IZL SEDECAL SA MOBILEDIAGNOST WDR

    Patients

    Seq Age Sex Outcome Treatment
    1