BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 8694980 · Received June 13, 2019

    Report

    Report Number
    3004123209-2019-00222
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    June 1, 2019
    Report Date
    July 11, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6)2014. CAPACITOR C9 WAS MEASURED AND FOUND TO HAVE FAILED. C9 IS USED TO PREVENT THE 18V LINE DROPPING LOW DURING THE INITIAL CHARGE CYCLE. A BREAKDOWN OF C9 WOULD RESULT IN AN 18V SHORT TO GROUND. THIS WOULD HAVE CAUSED THE RETURNED PAD-PAK TO BLOW ITS FUSE WHICH WOULD RESULT IN THE DEVICE NOT BEING ABLE TO SWITCH ON AS PER THE REPORTED FAULT. DURING TESTING A TEST PAD-PAK WAS INSTALLED INTO THE DEVICE AND THE FUSE WAS BLOWN BY THE DEVICE. THE FUNCTIONALITY OF THE CIRCUIT IS TESTED AT BOTH H017-014-103 PBA TEST AND H017-014-104 FINAL. THEREFORE, IT IS CONCLUDED THAT THE COMPONENT FAILED AFTER DISPATCH. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT THE HISTORY LOG UNTIL THE 3RD (B)(6)2019, THEREFORE, IT IS ASSUMED THE COMPONENT FAILED AFTER THIS TIME. FURTHERMORE, AFTER REPLACING CAPACITOR C9, THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0°C AND 50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS IS EQUIVALENT TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT FAULT.

    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

    DEVICE WILL NOT SWITCH ON. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    DEVICE WILL NOT SWITCH ON. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488917 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1