BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1883830 · Received October 21, 2010

    Report

    Report Number
    1218950-2010-02003
    Event Type
    Death
    Date Received
    October 21, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 21, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED THAT DEVICE CANCELLED A SHOCK IN THE AED MODE. THE INVOLVED PATIENT DIED. IT HAS NOT YET BEEN DETERMINED WHAT ROLE THE DEVICE BEHAVIOR PLAYED IN THE PATIENT OUTCOME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT DEVICE CANCELLED A SHOCK IN THE AED MODE. THE INVOLVED PATIENT DIED. IT HAS NOT YET BEEN DETERMINED WHAT ROLE THE DEVICE BEHAVIOR PLAYED IN THE PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death