BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5540711 · Received April 1, 2016

    Report

    Report Number
    3004123209-2016-00422
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    March 23, 2016
    Report Date
    May 12, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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). ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG SHOWED THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 22ND MARCH 2013 AND PERFORMED TO SPECIFICATION UP TO THE 27TH DECEMBER 2015. DURING THIS TIME THE DEVICE RECORDS MULTIPLE OCCASIONS IN WHICH THE TEMPERATURE WAS RECORDED OUTSIDE THE OPERATING RANGE FOR THIS DEVICE (0-50 DEGREES CELSIUS) WITH A LOW OF -12 DEGREES CELSIUS AND A HIGH OF 53.9 DEGREES CELSIUS. ON THREE OCCASIONS THIS TRIGGERED THE DEVICE TO ISSUE A TEMPERATURE FAIL WARNING VIA THREE AUDIBLE BEEPS. ON THE 3RD JANUARY 2016 THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO A LOW BATTERY. INVESTIGATION FOUND ADVERSE STORAGE CONDITIONS RESULTED IN THE DEVICE ISSUING A LOW BATTERY WARNING. THE BATTERY MONITORING CIRCUITRY WAS VERIFIED DURING THE INVESTIGATION AND THE DEVICE TEMPERATURE CYCLED BETWEEN 0-50 DEGREES CELSIUS FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS EQUATES TO APPROXIMATELY 33 MONTHS OF NORMAL OPERATION WITHOUT FAULT.

    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

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PAD UNIT HAS FLASHING RED STATUS INDICATOR LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198632 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1