BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2497866 · Received March 14, 2012

    Report

    Report Number
    1218950-2012-00899
    Event Type
    Death
    Date Received
    March 14, 2012
    Date of Event
    February 12, 2012
    Report Date
    February 16, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED AN UNEXPECTED SHUT DOWN DURING A PATIENT EVENT. THERE IS NO REPORT THAT DEVICE BEHAVIOR IMPACTED PATIENT OUTCOME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNEXPECTED SHUT DOWN DURING A PATIENT EVENT. THERE IS 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 MEDICAL SYSTEMS-DUP M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death