BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 4080459 · Received July 24, 2014

    Report

    Report Number
    1518293-2014-00065
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) CONFIRMED REPORT THAT THE CONSOLE DISPLAY WOULD NOT COME ON AND REPLACED THE GENERATOR CONSOLE AND VERIFIED PROPER OPERATION ACCORDING TO SERVICE MANUAL (B)(4). FSE VERIFIED OPERATION OF TABLE FUNCTIONS ACCORDING TO HYDRAVISION DR SERVICE MANUAL AND RETURNED THIS UNIT TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT STAFF WERE PERFORMING RETROGRADE CYSTOGRAPHY PROCEDURE ON A (B)(6) YEAR OLD MALE WHEN THE SYSTEM FLUORO FAILED. PROCEDURE WAS ABORTED BY THE PHYSICIAN. CUSTOMER PROVIDES NO FURTHER INFO, OTHER THAN TO SAY PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433357 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM HUT EXT DR FINAL A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR