BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD PAK

    MDR report key: 6964170 · Received October 20, 2017

    Report

    Report Number
    3004123209-2017-01206
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 27, 2017
    Report Date
    January 25, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. (B)(4). 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 THE (B)(6) 2014 AND THAT IT HAD PERFORMED TO ALL WEEKLY AUTO SELF-TESTS UP TO AND INCLUDING THE LAST LOG ENTRY, PRIOR TO RECEIPT AT HEARTSINE, ON THE (B)(6) 2017. THE RETURNED SAM 500P PASSED "OUT QAT" FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2013. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR ANALYSER USING THE RETURNED PAD-PAK AND THE DEVICE DELIVERED A TEST SHOCK WITHOUT FAULT. PREVIOUS EXPERIENCE HAS SHOWN THAT A LEAKAGE CURRENT ACROSS ONE OF THE TRANSISTORS IN THE CIRCUIT MAY RESULT IN UNCHARACTERISTIC LIGHTING OF THE STATUS LEDS AND COULD POTENTIALLY CAUSE BOTH LEDS TO FLASH SIMULTANEOUSLY. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE AND THE LED DRIVE WAS SCRUTINIZED WITH NO MEASURABLE FAULT FOUND. AN INTERMITTENT COMPONENT FAILURE MAY HAVE RESULTED IN THE REPORTED FAULT AND AN EXCESS CURRENT DRAIN. 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

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. RED AND GREEN STATUS INDICATORS DISPLAYED SIMULTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744508 HEARTSINE SAMARITAN 500P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1