BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5821538 · Received July 26, 2016

    Report

    Report Number
    3004123209-2016-00923
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 30, 2016
    Report Date
    September 2, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. ROUTINE TESTING CONFIRMED THAT THE PAD-PAK WAS FIRST WAS INSTALLED BY THE CUSTOMER ON THE 9TH FEBRUARY 2011 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2015. 68 MANUAL POWER UPS OF UNDER ONE MINUTE DURATION WERE RECORDED AND WOULD LIKELY INDICATE THE USER WAS REGULARLY POWER CYCLING THE DEVICE. THE DEVICE RECORDS MANUAL POWER UPS OF 10 MINUTES DURATION BETWEEN THE (B)(6) 2015 AND THE (B)(6) 2015. THE DEVICE FAILED MULTIPLE SELF-TESTS DUE TO A LOW BATTERY BETWEEN THE (B)(6) 2016. INVESTIGATION FOUND THE FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS AND THE EXCESS CURRENT DRAIN MEASURED DURING THE INVESTIGATION WOULD CONFIRM A FAILING MEMBRANE. THE FAULT COULD NOT BE MEASURED WITH A NEW MEMBRANE FITTED. 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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477028 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1