BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4792304 · Received May 18, 2015

    Report

    Report Number
    3004123209-2015-00512
    Event Type
    Death
    Date Received
    May 18, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 30, 2015
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. THE DEVICE WAS USED IN SCA EVENT. END USER SAYS THAT UNIT NEVER GOT OUT OF ANALYZING PHASE OF VERBAL PROMPTS (IE NO SHOCK ADVISED NO CPR CYCLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321322 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death