BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI DIAGNOST I

    MDR report key: 2061571 · Received March 16, 2011

    Report

    Report Number
    3003768277-2011-00294
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    January 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAA
    PMA / PMN Number
    K904012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT: "THE SYSTEM WILL SHOW A GREEN READY LIGHT BUT WILL NOT FLUOROSCOPY. DIGITAL IMAGES ARE AVAILABLE." THE ERROR CODE IS: "SYSTEM CONTROLLER PROBLEM OR ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI DIAGNOST I JAA PHILIPS HEALTHCARE 70839

    Patients

    Seq Age Sex Outcome Treatment
    1