BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS V3000

    MDR report key: 2062299 · Received March 18, 2011

    Report

    Report Number
    3003768277-2011-00293
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    February 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K910370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE EXAM IN A TECHNICAL ROOM, A LOUD NOISE WAS HEARD AND SMOKE CAME OUT. NOW THE SYSTEM IS COMPLETELY OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS V3000 IZI PHILIPS HEALTHCARE 72243

    Patients

    Seq Age Sex Outcome Treatment
    1