BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3516639 · Received November 18, 2013

    Report

    Report Number
    3004123209-2013-01846
    Event Type
    Death
    Date Received
    November 18, 2013
    Date of Event
    November 8, 2013
    Report Date
    November 13, 2013
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED IN A SCA EVENT WHERE THE PATIENT EXPIRED. THE PAD-PAK FROM LOT 771 WAS WITHIN 1 MONTH OF THE EXPIRY DATE (NOVEMBER 2013) AND A LOW BATTERY WARNING WAS ISSUED DURING THE EVENT. NO SHOCK WAS DELIVERED DURING THE EVENT. UNIT HAD MEMORY FULL MESSAGE UPON POWERING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596215 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death