BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4188264 · Received September 19, 2014

    Report

    Report Number
    3004123209-2014-01149
    Event Type
    Death
    Date Received
    September 19, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 10, 2014
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THERE WAS A PT INVOLVED IN THIS EVENT: THE PAD UNIT USED IN AN SCA EVENT HAS ADULT PT AUDIBLE WITH PEDIATRIC PAD-PAK INSTALLED ACCORDING TO END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581374 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death