BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6793663 · Received August 15, 2017

    Report

    Report Number
    3004123209-2017-00836
    Event Type
    Malfunction
    Date Received
    August 15, 2017
    Date of Event
    July 26, 2017
    Report Date
    October 18, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY BY THE USER ON (B)(6) 2010. THE DEVICE RECORDS MULTIPLE FAILED AUTO SEF TESTS ON (B)(6) 2017 AND THE FINAL ENTRY ON (B)(6) 2017. INVESTIGATION FOUND THE FAULT CAN BE ATTRIBUTED TO MEMBRANE. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED IN SECTION H8 OF THIS REPORT.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575748 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1