BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS FR3 AED

    MDR report key: 5990514 · Received September 29, 2016

    Report

    Report Number
    MW5065102
    Event Type
    Death
    Date Received
    September 29, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 29, 2016
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O MALE, BYSTANDER, CPR IN PROGRESS, FD ARRIVED AND CONTINUE WITH CPR AND APPLIED FR3 AED. DURING INCIDENT, ISSUES WITH PROLONGED AED ANALYSIS OF CARDIAC RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639427 PHILIPS FR3 AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHILIPS HEALTHCARE FR3

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death