BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDIAGNOST ELEVA WITH FLAT

    MDR report key: 2063012 · Received March 21, 2011

    Report

    Report Number
    3003768277-2011-00289
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    February 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K050151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE SYSTEM REPORTS THAT IT IS READY FOR EXPOSURE. HOLDING THE PEDAL IN FOR A WHILE WILL NOT RESULT IN A PICTURE. AFTER THE RESTART IT WAS THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIDIAGNOST ELEVA WITH FLAT IZI, KPR IZI PHILIPS HEALTHCARE 708034

    Patients

    Seq Age Sex Outcome Treatment
    1