BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV LIBRA 9"

    MDR report key: 1971741 · Received December 30, 2010

    Report

    Report Number
    3003768277-2010-00417
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Report Date
    October 19, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K0101762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS) - THE INVESTIGATION FOUND THAT THE HT CONVERTER TANK WAS DEFECTIVE. WHEN IT BECOMES DEFECTIVE, IMAGING CAPABILITY OF THE SYSTEM IS LOST. ALL SYSTEM MATERIALS ARE UL CERTIFIED AND THE SYSTEM WAS NOT DOWN. HOWEVER, THE SYSTEM IS AN OLD MOBILE SURGERY SYSTEM WHICH CAN BE EASILY REPLACED IN CASE OF EMERGENCY. ALSO, IT IS UNLIKELY THAT THIS SYSTEM WILL BE USED FOR COMPLEX INTERVENTIONAL PROCEDURES. FAILURE RATES AND RELIABILITY OF COMPONENTS ARE MONITORED AND THE REPLACED COMPONENT DOES NOT HAVE ANY EXCEPTIONAL OR INCREASED FAILURE RATE. THERE IS NO REQUIRED MANDATORY FIELD ACTION.

    Description of Event or Problem · 1

    SMOKE CAME OUT FROM THE INSIDE OF THIS X-RAY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV LIBRA 9" IZL (MOBILE X-RAY SYSTEM) IZL PHILIPS MEDICAL SYSTEMS 718030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1