BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 3941650 · Received March 5, 2014

    Report

    Report Number
    3003768277-2014-00017
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Report Date
    February 10, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER (FSE) TROUBLESHOT THE SYSTEM AND FOUND A PROBLEM WITH THE POWER TRAY AND THE FUSE. HE REPLACED THE POWER TRAY AND FUSE, THIS SOLVED THE PROBLEM.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT A POWER TRAY UNIT DID NOT FUNCTION DURING CLINICAL USE. THE FUSE WAS BLOWN AND THE SYSTEM WOULD NOT POWER UP. THERE WAS NO HARM TO PATIENT. THE PATIENT WAS MOVED TO ANOTHER ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131654 ALLURA XPER FD20 IZI PHILIPS HEALTHCARE 722006

    Patients

    Seq Age Sex Outcome Treatment
    1