BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 5664268 · Received May 18, 2016

    Report

    Report Number
    1518293-2016-00041
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 28, 2016
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CALLED SERVICE REPORTING THEY WERE GETTING A `SYSTEM MISALIGNED' MESSAGE ON THE TABLE TUBE SHROUD DISPLAY. SYSTEM IS DESIGNED TO NOT FLUORO IF SYSTEM ISN'T PROPERLY ALIGNED. SERVICE HAD HIM ATTEMPT TO MOVE THE IMAGE SYSTEM VIA THE HAND SWITCH, BUT THE IMAGING SYSTEM WOULD NOT MOVE. IN ONE DIRECTION IT SAYS THE TRAVEL LIMITS HAVE BEEN REACHED, AND IN THE OTHER DIRECTION HE JUST HEARS A MOTOR SOUND, BUT NEITHER THE IMAGE INTENSIFIER OR TUBE ARM WILL MOVE. CUSTOMER WANTED TO HAVE A FIELD SERVICE ENGINEER (FSE) COME TO THE SITE. FSE WENT ON SITE AND FOUND TRANSDUCER BOARD AT FOOT END OF TABLE CAUSING MISALIGNMENT PROBLEM. FSE REPLACED THE TRANSDUCER BOARD AND VERIFIED PROPER OPERATION PER SERVICE CHECKLIST QSSRWI4.1 AND RETURNED THE UNIT TO THE CUSTOMER FOR FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DURING A STENT PLACEMENT THE FLUORO FAILED WITH A SYSTEM ALIGNMENT ISSUE. STAFF PLACED THE STENT WITH THE ENDOSCOPE AND DID A FOLLOW UP RADIOGRAPH AFTER THE PROCEDURE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319871 HUT EXT DR FINAL ASSY-STANDARD HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD

    Patients

    Seq Age Sex Outcome Treatment
    1