BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY - STANDARD

    MDR report key: 2447141 · Received January 31, 2012

    Report

    Report Number
    1518293-2012-00020
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 31, 2012
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    KQS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOT TO A FAILING 24V POWER SUPPLY THAT WOULD NOT REGULATE AND REPLACED THE POWER SUPPLY. FSE ALSO FOUND THE MONITOR COLLISION ERROR WAS DUE TO FAILED TAPE SWITCH. THE SWITCH SHOULD BE OPEN OR CLOSED AND THIS TAPE SWITCH WOULD NOT FULLY OPEN. FSE ORDERED A NEW MONITOR COLLISION TAPE SWITCH WHICH THE CUSTOMER WANTS TO INSTALL. ON (B)(6), FSE CONTACTED CUSTOMER WHO REPORTED THE TAPE SWITCH WAS INSTALLED AND THE SYSTEM IS WORKING PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6), CUSTOMER REPORTS VIA PHONE DURING A UNK PT UROLOGY PROCEDURE, WHEN THEY TRIED TO MOVE THE X-RAY TUBE OR MONITORS, THE SYSTEM WOULD SHUT COMPLETELY DOWN. CUSTOMER REPORTS SYSTEM WAS UNABLE TO BE REBOOTED. PHYSICIAN COMPLETED PROCEDURE. NO PT INJURIES WERE REPORTED. PT GENDER AND AGE WERE NOT KNOWN. FACILITY DOES HAVE BACK-UP CAPABILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY - STANDARD KQS LIEBEL-FLARSHEIM CO HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK