BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5382317 · Received January 21, 2016

    Report

    Report Number
    3004123209-2016-00073
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    January 15, 2016
    Report Date
    June 17, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2011 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2015. AN INCREASE IN VOLTAGE SUGGESTS A FURTHER PAD-PAK WAS INSTALLED. MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION WERE OBSERVED IN THE DEVICE MEMORY BETWEEN THE (B)(6) 2015. THE PAD-PAK WAS REMOVED AND REINSTALLED ON MULTIPLE OCCASIONS DURING THIS TIME. A TEST PAD-PAK WAS INSERTED INTO THE DEVICE AND PASSED A SELF-TEST. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. AN ACCEPTABLE SHOCK WAS DELIVERED DURING THE TESTING. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE DUE TO MOISTURE INGRESS. THE TEN MINUTE TIME OUTS RECORDED MAY INDICATE FAILURE OF THE MEMBRANE OR A COMPONENT. INVESTIGATION WAS UNABLE TO REPLICATE THE REPORTED FAULT HOWEVER CONTAMINATION WAS OBSERVED UNDER THE ON BUTTON WHICH MAY HAVE RESULTED IN THE DEVICE SWITCHING ON AUTOMATICALLY. THIS WOULD INDICATE THE DEVICE WAS STORED IN ADVERSE CONDITIONS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42709 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1