BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 6126161 · Received November 23, 2016

    Report

    Report Number
    3030677-2016-02806
    Event Type
    Death
    Date Received
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER IS QUESTIONING THE "ANALYZING PATIENT" AND "ANALYZING WAS DISRUPTED"VOICE PROMPTS THE DEVICE ISSUED DURING A PATIENT USE EVENT. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776663 HEARTSTREAM FR2 AED MKJ PHILIPS MEDICAL SYSTEMS M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death