BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4307440 · Received December 2, 2014

    Report

    Report Number
    3004123209-2014-01878
    Event Type
    Death
    Date Received
    December 2, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 27, 2014
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THERE WAS A PT INVOLVED IN THIS EVENT. A DEVICE MALFUNCTIONED BECAUSE PAD UNIT WAS USED IN AN SCA EVENT, ON THIRD SHOCK DELIVERED TO PT THE UNIT EMITTED A HUMMING SOUND AND ALL OF THE ICON LIGHTS ON THE MEMBRANE LIT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776083 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death