BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4188185 · Received October 3, 2014

    Report

    Report Number
    3004123209-2014-01233
    Event Type
    Death
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 24, 2014
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. THIS UNIT WAS USED IN AN SCA EVENT WHERE THE PATIENT DIED. THE UNIT WAS STORED WITHOUT A PAD-PAK INSTALLED. WHEN ENDUSER WENT TO USE THE UNIT, THE PAD-PAK WAS INSTALLED INCORRECTLY MAKING THE UNIT INCAPABLE OF DELIVERING THERAPY IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617345 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death