BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 4902475 · Received July 9, 2015

    Report

    Report Number
    1518293-2015-00057
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED REPORT THAT THE FLUORO WOULD STOP WORKING AND THE OPERATOR WOULD RESET THE GENERATOR AND IT WOULD START WORKING, BUT COULD NOT DUPLICATE THE PROBLEM. FSE RE-SYNCED THE GENERATOR AND THE CONSOLE. FSE TESTED THE SYSTEM PER SERVICE CHECKLIST AND RETURNED UNIT TO FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING A UROLOGY CYSTOSCOPY PROCEDURE THE FLUORO FAILED. STAFF MOVED THE PATIENT TO ANOTHER ROOM TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. NO REPORTED INJURY. NO ADDITIONAL DETAILS ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446818 HUT EXT DR FINAL ASSY-STANDARD IXR IXR LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1