BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 3082851 · Received April 16, 2013

    Report

    Report Number
    1218950-2013-01396
    Event Type
    Death
    Date Received
    April 16, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILLIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE DURING A PT EVENT. THE INVOLVED PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163321 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death