BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX

    MDR report key: 1874494 · Received October 15, 2010

    Report

    Report Number
    1218950-2010-01965
    Event Type
    Death
    Date Received
    October 15, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 12, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE VIA EXTERNAL PADDLES. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO DELIVER THERAPY. THE PT'S RHYTHM WAS CONVERTED TO A NORMAL RHYTHM AND THE PT'S BLOOD PRESSURE WAS NORMAL. TWO HOURS LATER, THE PT SUFFERED A CARDIAC ARREST AND DIED. THE CUSTOMER DOES NOT BELIEVE THAT THE FAILURE TO DISCHARGE WITH THE FIRST DEFIBRILLATOR PLAYED A ROLE IN THE OUTCOME FOR THIS PT. THE PT WAS SUCCESSFULLY RESUSCITATED BUT HAD A SUBSEQUENT CARDIAC ARREST. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE VIA EXTERNAL PADDLES. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO DELIVER THERAPY. THE PT'S RHYTHM WAS CONVERTED TO A NORMAL RHYTHM AND THE PT'S BLOOD PRESSURE WAS NORMAL. TWO HOURS LATER THE PT SUFFERED A CARDIAC ARREST AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death