BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATORQ

    MDR report key: 3497395 · Received November 25, 2013

    Report

    Report Number
    1218950-2013-06101
    Event Type
    Death
    Date Received
    November 25, 2013
    Date of Event
    October 31, 2013
    Report Date
    November 4, 2013
    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). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT DURING A CARDIAC ARREST, THE CAPNOGRAPHY ON THE HEARTSTART MRX WAS NOT GIVING A READING. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611311 HEARTSTART MRX-EMS DEFIBRILLATORQ MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death