BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1713898 · Received June 4, 2010

    Report

    Report Number
    1218950-2010-00846
    Event Type
    Death
    Date Received
    June 4, 2010
    Report Date
    April 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K03118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE DEVICE BEGAN ANALYZING UNEXPECTEDLY WHEN IN USE ON A PT. THE PT DIED. THERE WAS NO INDICATION THAT DEVICE BEHAVIOR IMPACTED PT OUTCOME. THE DATE OF THE EVENT AND PT DEATH ARE UNK. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE BEGAN ANALYZING UNEXPECTEDLY WHEN IN USE ON A PT. THE PT DIED. THERE WAS NO INDICATION THAT DEVICE BEHAVIOR IMPACTED PT OUTCOME. THE DATE OF THE EVENT AND PT DEATH ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536J

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death