BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 3912074 · Received May 13, 2014

    Report

    Report Number
    1518293-2014-00053
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO INVESTIGATE BUT COULD NOT DUPLICATE THE NO FLUORO ISSUE. FSE DID FIND A PROBLEM WITH THE TABLE HANDSWITCH IN THAT THE TABLE MOVEMENTS WOULD STOP AND SOMETIMES THE PARK ARM WOULD BE CLOSE TO THE X-RAY POSITION BUT NOT QUITE THERE. FSE TROUBLESHOT THE PROBLEM TO A BAD HANDSWITCH CABLE, AND RESOLVED BY REPLACING THAT COILED CABLE. FSE CHECKED SYSTEMS FOR PROPER OPERATION PER SERVICE CHECKLIST AND RETURNED THE UNIT TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE SYSTEM LOST FLUORO CAPABILITY AND STAFF HAD TO COMPLETED THE PROCEDURE USING RAD IMAGES. CUSTOMER PROVIDED NO PATIENT OR PROCEDURAL INFORMATION, OTHER THAN TO SAY THE PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285324 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM HUT EXT DR FINAL A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK