BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 5538943 · Received March 31, 2016

    Report

    Report Number
    1518293-2016-00028
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 15, 2016
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CALLED SERVICE REPORTING A GENERATOR INTERFACE MALFUNCTION (GIM) ERROR BEING DISPLAYED. TECH SERVICE TROUBLESHOT WITH CUSTOMER HAVING THEM UNPLUG THE GIM FOR 30 SECONDS AND PLUG BACK IN, WHICH UNLOCKED THE GIM, BUT CUSTOMER WAS NOT ABLE TO DO A WARM UP SHOT. THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND REPLACED THE GIM AND TESTED FOR PROPER OPERATION. SYSTEM WAS THEN CHECKED PROPER FUNCTION PER SERVICE CHECKLIST QSSRWI4.1 AND RETURNED TO THE CUSTOMER FOR FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE SYSTEM FAILED DURING A STENT PLACEMENT PROCEDURE. STAFF WAS ABLE TO FINISH THE PROCEDURE WITHOUT FLUORO. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195074 HUT EXT DR FINAL ASSY-REVERSE HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

    Patients

    Seq Age Sex Outcome Treatment
    1