BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3802953 · Received April 30, 2014

    Report

    Report Number
    1218950-2014-02327
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 17, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE AND ACCESSORIES WERE EVALUATED ONSITE BY A PHILIPS FIELD SERVICE ENGINEER. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. THE ETCO2 PORT WAS CLEANED AND ETCO2 WAS CALIBRATED BY THE FSE. THE DEVICE PASSED ALL REQUIRED PERFORMANCE VERIFICATION TESTING. PHILIPS WAS UNABLE TO VERIFY THE REPORTED MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART MRX DEFIBRILLATOR COULD NOT ACQUIRE ETCO2 ON A PT IN CARDIAC ARREST. THE PARAMEDICS SWITCHED TO ANOTHER MRX DEFIBRILLATOR TO CONTINUE CARE. THE INVOLVED PT WAS PRONOUNCED AFTER BEING TRANSPORTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258142 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death