BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2243367 · Received September 7, 2011

    Report

    Report Number
    1218950-2011-02643
    Event Type
    Death
    Date Received
    September 7, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT DURING A PT EVENT THEY WERE UNABLE TO OBTAIN ETCO2 CAPNOGRAPHY. THE ETCO2 DEVICE FUNCTION DOES NOT AFFECT THE DELIVERY OF THERAPY, ALTHOUGH DUE TO THE PT'S OUTCOME WE ARE REPORTING THIS AS A MALFUNCTION. THE DEVICE WAS EVALUATED BY PHILIPS. THE REPORTED SYMPTOM WAS REPRODUCED. REPLACEMENT OF THE PT CONNECTOR ASSEMBLY AND ETCO2 MODULE RESOLVED THE REPORTED SYMPTOM. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER. WE ARE UNABLE TO DETERMINE THE CAUSE SINCE MULTIPLE PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PT EVENT THEY WERE UNABLE TO OBTAIN ETCO2 CAPNOGRAPHY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death