BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6867912 · Received September 15, 2017

    Report

    Report Number
    3004123209-2017-00984
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    August 22, 2017
    Report Date
    October 19, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 DEVICE HISTORY RECORDS FOR THE RETURNED SAM 300P DEVICE WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, BELFAST ON 18TH JULY 2014. ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2014 AND PERFORMED TO SPECIFICATION UP UNTIL (B)(6) 2017. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR AND DELIVERED MULTIPLE TEST SHOCKS WITHOUT FAULT. THE DEVICE WAS CONNECTED TO THE SAVER EVO APPLICATION AND THE "RUN DIAGNOSTIC TESTS" TOOL WAS USED TO VERIFY THE OPERATION OF THE SHOCK BUTTON AND THE SHOCK KEY LEDS. THE SHOCK KEY ICON TEST WAS EXECUTED TO VERIFY THE OPERATION OF THE SHOCK KEY LEDS. ALL FOUR SHOCK KEY LEDS ILLUMINATED AS EXPECTED FOR THE FIVE SECOND TEST. IN USB MODE, THE DEVICE IS NOT ABLE TO ANALYSE OR DELIVER SHOCK THERAPY. THE DIAGNOSTIC TESTS THAT CAN BE RUN WHEN THE DEVICE IS CONNECTED TO SAVER EVO VIA USB ARE ONLY TO CONFIRM FUNCTIONALITY OF THE USER INTERFACE. THEREFORE, NO SHOCK WILL BE DELIVERED DURING THE SHOCK KEY OPERATION TEST, THIS TEST ONLY VERIFIES THE SHOCK KEY IS OPERATING CORRECTLY AND REQUIRES USER INTERVENTION TO SUCCESSFULLY COMPLETE IT. 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. SHOCK BUTTON DOES NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651031 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1