BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART HOME

    MDR report key: 6004972 · Received October 6, 2016

    Report

    Report Number
    3030677-2016-02389
    Event Type
    Death
    Date Received
    October 6, 2016
    Date of Event
    September 4, 2016
    Report Date
    October 6, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NSA
    PMA / PMN Number
    020715
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE USER IS QUESTIONING THE FUNCTIONALITY OF THE DEVICE DURING A PATIENT USE EVENT. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656947 HEARTSTART HOME AED NSA PHILIPS MEDICAL SYSTEMS M5068A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death