BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMX DEFIBRILLATOR

    MDR report key: 1366845 · Received February 6, 2009

    Report

    Report Number
    1218950-2009-00160
    Event Type
    Malfunction
    Date Received
    February 6, 2009
    Report Date
    November 20, 2008
    Manufacturer
    PHILLIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED GETTING MULTIPLE "EXTERNAL PADDLES CONNECTED" MESSAGES WHEN THE EXTERNAL PADDLES WERE NOT CONNECTED. BOTH THE DEVICE AND THE THERAPY CABLE WERE TO BE EVALUATED AT PHILLIPS. THE UNIT WAS EVALUATED AT PHILLIPS, BUT THE SYMPTOM COULD NOT BE VERIFIED. THE DEVICE PASSED ALL TESTING. THE THERAPY CABLE COULD NOT BE EVALUATED AT PHILLIPS, HOWEVER, SINCE IT WAS DISCARDED BY THE CUSTOMER. A REPLACEMENT THERAPY CABLE WAS PROVIDED TO THE CUSTOMER. AS OF 02/05/2009, THE CUSTOMER HAS NOT CALLED BACK REGARDING THIS DEVICE. WE ARE CONSIDERING THIS FAILURE A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE SINCE THE THERAPY CABLE WAS NOT RETURNED, AND THE DEVICE PASSED ALL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING MULTIPLE "EXTERNAL PADDLES CONNECTED" MESSAGES WHEN THE EXTERNAL PADDLES WERE NOT CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX-EMX DEFIBRILLATOR MKJ PHILLIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1