BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY,ST,FPD

    MDR report key: 5083855 · Received September 17, 2015

    Report

    Report Number
    1518293-2015-00085
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 19, 2015
    Report Date
    October 30, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    MQB
    PMA / PMN Number
    K121838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SERVICE FOLLOWED UP WITH CUSTOMER WHO REPORTED THEY HAD CYCLED POWER TO THE GIM AND NOW THE SYSTEM WAS WORKING WITHOUT ISSUE. WHEN THE GENERATOR INTERFACE MALFUNCTION (GIM) LOCKED UP, IT CAUSED THE SYSTEM LOCK OUT AND STOPPED MAKING X-RAY. FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THE ERROR MESSAGE OF GIM COMMUNICATIONS FAILURE AND REPLACED THE GIM AND REPLACED THE AEC CONTROL PCB. FSE NOTED THE THREE CABLES TO THE DETECTOR WERE SLIGHTLY DAMAGED (KINKED, TWISTED) AND REPLACED THESE CABLE TO POSSIBLY IMPROVE THE IMAGE. FSE TESTED FOR PROPER OPERATION PER SERVICE CHECKLIST (B)(4). GIM AND AEC CONTROL BOARD WERE RETURNED TO LIEBEL FLARSHEIM (LF). PRODUCT ENGINEERING EVALUATED THE AEC BOARD AND COULD NOT DUPLICATE THE PROBLEM, AND CHECKED THE GIM AND ALSO COULD NOT DUPLICATE THE LOST COMMUNICATION ISSUE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT DURING AN UNKNOWN PROCEDURE THE SYSTEM FLUORO FAILED WITH A GENERATOR INTERFACE MALFUNCTION. THE PATIENT WAS MOVED TO ANOTHER ROOM AND COMPLETED WITH A C-ARM. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617226 HUT EXT DR FINAL ASSY,ST,FPD HUT EXT DR FINAL ASSY,ST,FPD MQB LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY,ST,FPD

    Patients

    Seq Age Sex Outcome Treatment
    1