BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 4905012 · Received July 10, 2015

    Report

    Report Number
    1518293-2015-00059
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED CUSTOMER'S REPORT THAT THEY COULD NOT FLOURO. THEY HAD RESET THE GENERATOR AND IT STARTED TO WORK. FSE COULD NOT DUPLICATE THE PROBLEM. FSE SYNCED THE GENERATOR, TESTED THE SYSTEM PER CHECKLIST AND RETURNED THE UNIT TO FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE FLUORO FAILED DURING A KIDNEY PROCEDURE. THE PHYSICIAN OPTED TO CANCEL THE PROCEDURE RATHER THAN USING THE C-ARM FLUORO UNIT. NO REPORTED INJURY. NO ADDITIONAL DETAILS ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450734 HUT EXT DR FINAL ASSY-REVERSE IXR IXR LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly