BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 6739647 · Received July 25, 2017

    Report

    Report Number
    3004123209-2017-00710
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    September 28, 2017
    Report Date
    August 30, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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).

    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 350P 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 350P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE 17TH OF SEPTEMBER 2015. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2016 AND HAD PERFORMED TO SPECIFICATION, UP TO (B)(6) 2017. MULTIPLE MANUAL POWER UPS MAINLY OF TEN MINUTES DURATION WERE OBSERVED IN THE DEVICE MEMORY, BETWEEN (B)(6) 2017 AND THE LAST LOG ENTRY ON (B)(6) 2017. DURING THIS TIME AN INSTALLED PAD-PAK BECAME DEPLETED. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR AND DELIVERED A TEST SHOCK WITHOUT FAULT. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE AND CORROSION WAS OBSERVED ON MULTIPLE TRACKS OF THE 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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523253 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1