BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1883829 · Received October 21, 2010

    Report

    Report Number
    1218950-2010-02001
    Event Type
    Death
    Date Received
    October 21, 2010
    Date of Event
    September 19, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT DELIVER A SHOCK AS EXPECTED. THERE WAS NO REPORT THAT DEVICE BEHAVIOR IMPACTED 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

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT DELIVER A SHOCK AS EXPECTED. THERE WAS NO REPORT THAT DEVICE BEHAVIOR IMPACTED 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 53 YR Death