BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIDIAGNOST - CONVENTIONAL

    MDR report key: 2240925 · Received August 17, 2011

    Report

    Report Number
    3003768277-2011-00509
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 21, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K032046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION SHOWED THAT THE FIELD SERVICE ENGINEER TROUBLESHOT THE SYSTEM AND STATED THAT THE ROOT CAUSE WAS NOT CLEAR AS BOTH THE UNINTERRUPTED POWER SUPPLY (UPS) DIGITAL SPOT IMAGING (DSI) AS THE DSI COULD BE INVOLVED. THE UPS WAS REPLACED AND ADDITIONALLY THE DSI WAS UPGRADED TO R6.2. AFTER REPLACEMENT AND UPGRADE THE SYSTEM IS BACK TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DIGITAL PART OF SYSTEM (DSI) SWITCHED OFF SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIDIAGNOST - CONVENTIONAL IZI, JAA, KPR IZI PHILIPS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1