BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5437989 · Received February 16, 2016

    Report

    Report Number
    3004123209-2016-00242
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    February 11, 2016
    Report Date
    April 15, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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). 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 HISTORY LOG SHOWED THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE (B)(6) 2011 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2013. BETWEEN THE (B)(6) 2013 AND THE (B)(6) 2016 THE DEVICE RECORDS MANUAL POWER UPS OF UP TO TEN MINUTES DURATION. THE DEVICE PERFORMS SUCCESSFUL SELF-TESTS UP TO THE (B)(6) 2016. THE RETURNED 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. A TEST SHOCK WAS DELIVERED WITHOUT FAULT DURING TESTING. INVESTIGATION WAS UNABLE TO REPLICATE THE REPORTED FAULT. THE MANUAL POWER UPS MAY INDICATE THE USER WAS REGULARLY POWER CYCLING THE DEVICE OR THE BEGINNINGS OF MEMBRANE FAILURE. AT NO TIME DURING TESTING WAS THE DEVICE OBSERVED SWITCHING ON AUTOMATICALLY.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PAD UNIT POWERS ON WITHOUT END USER MANUAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94809 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1