BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS FR3 AED

    MDR report key: 5993212 · Received September 29, 2016

    Report

    Report Number
    MW5065120
    Event Type
    Death
    Date Received
    September 29, 2016
    Date of Event
    September 7, 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) MALE, UPON FD ARRIVAL, PT PULSELESS AND CAPNEIC. CPR INITIATED. PHILIPS FR3 APPLIED. DURING INCIDENT, ISSUES WITH PROLONGED AED ANALYSIS OF CARDIAC RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640421 PHILIPS FR3 AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHILIPS HEALTHCARE FR3

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death