BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 3922490 · Received June 2, 2014

    Report

    Report Number
    3003768277-2014-00057
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 7, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SVC ENGINEER (FSE) TROUBLE SHOT THE SYSTEM AND FOUND A PROBLEM WITH POWER SUPPLY IN THE MAIN CABINET. HE REPLACED THE POWER SUPPLY AND TESTED THE SYSTEM, THIS SOLVED THE PROBLEM.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT SYSTEM WOULD NOT RESPOND. IT WOULD NOT POWER UP. PT WAS BEING TRANSFERRED AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322063 ALLURA XPER FD10 IZI PHILIPS HEALTHCARE 722003

    Patients

    Seq Age Sex Outcome Treatment
    1