BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 3221841 · Received July 9, 2013

    Report

    Report Number
    1518293-2013-00155
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    July 9, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A PHONE CALL, THE CUSTOMER STATED WHILE ATTEMPTING TO START AN UNDETERMINED UROLOGY PROCEDURE THE SYSTEM STARTED SMOKING. AT A LATER DATE THIS CUSTOMER STATED THEY HAD REPLACED THE MONITOR POWER SUPPLY WHICH WAS THE SOURCE OF THE SMOKE ISSUE. THE SYSTEM FUNCTIONED NORMALLY. THERE WAS NO ADDITIONAL SERVICE PERFORMED OR SERVICE CALL PLACED BY CUSTOMER, WHO MADE ALL REPAIRS THEMSELVES.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE THAT STAFF WERE ATTEMPTING TO START AN UNDETERMINED UROLOGY PROCEDURE WHEN THE SYSTEM STARTED SMOKING. STAFF MOVED THE PT FROM THE TABLE TO ANOTHER ROOM WHERE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. CUSTOMER WAS NOT ABLE TO PROVIDE ANY ADDITIONAL INFO WITH REGARDS TO THE PROCEDURE OR PT. NO REPORTED INJURY. ON (B)(4) 2013 ON A FOLLOW UP PHONE CALL, BIOMED CONFIRMED THE SMOKE WAS A VISIBLE SMOKE THAT WAS RELATED TO THE POWER SUPPLY OF THE MONITOR AND THERE WAS NOT ANY GENERATOR INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312913 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK