BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4792298 · Received May 18, 2015

    Report

    Report Number
    3004123209-2015-00549
    Event Type
    Death
    Date Received
    May 18, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 11, 2015
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. THE PAD UNIT WAS USED IN AN SCA EVENT, END USER SAYS UNIT NEVER GOT TO ANALYZING PHASE OF VERBAL PROMPTS (IE: NO SHOCK/SHOCK ADVISED NO CPR CYCLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321478 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death