BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNOST EPC

    MDR report key: 148845 · Received February 6, 1998

    Report

    Report Number
    1217116-1998-00002
    Event Type
    Malfunction
    Date Received
    February 6, 1998
    Date of Event
    January 9, 1998
    Report Date
    January 9, 1998
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE C-ARM KEPT MOVING UPWARD AFTER USER RELEASED UPSWITCH AND THE C-ARM STRUCK THE BOTTOM OF THE TABLE. REPORTEDLY, THE ANTI-COLLISION SWITCH DID NOT STOP C-ARM MOVEMENT. USER HAD TO TURN MAIN POWER OFF TO THE UNIT TO STOP C-ARM MOVEMENT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAGNOST EPC RADIOGRAPHIC TABLE (WITH C-ARM) KXJ PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 9804-018-33007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other