BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7420605 · Received April 11, 2018

    Report

    Report Number
    3004123209-2018-00260
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    March 1, 2018
    Report Date
    June 12, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    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: DEVICE NOT RETURNED YET.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED. THE DEVICE WAS PREVIOUSLY RETURNED AND INVESTIGATED, UNDER F001-EU16-004 ON THE 6TH JANUARY 2016. THE DETAILS OF COMPLAINT WERE ¿COMMERCIAL RETURN, NO REPORTED FAULT¿. THE INVESTIGATION CONCLUDED THAT THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING. HARDWARE AND SOFTWARE UPGRADES AS PER H004-003-004-3 AND FINAL TEST (H017-014-104) WERE IMPLEMENTED. THE SAM 300P LAST PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 27TH JUNE 2016. C9 WAS MEASURED AND FOUND TO HAVE FAILED. C9 IS USED TO PREVENT THE 18V LINE DROPPING LOW DURING THE INITIAL CHARGE CYCLE. IN THIS CASE, FAILURE OF C9 CAPACITOR HAD CAUSED THE DEVICE TO FAIL TO POWER OFF. THIS WOULD ACCOUNT FOR THE MULTIPLE MANUAL POWER CYCLES OF A CONTINUOUS NATURE AND OF TEN MINUTES DURATION RECORDED IN THE HISTORY LOG. THE FAULT WAS WITNESSED DURING THE INVESTIGATION AND COULD NOT BE REPLICATED WHEN C9 WAS REPLACED.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 FAILED TO SHUTDOWN CORRECTLY FOLLOWING THE WEEKLY AUTO SELF-TEST ON THE 5TH MARCH 2017, THEREFORE IT IS ASSUMED THE CAPACITOR FAILED AROUND THIS TIME.AFTER THE C9 WAS REPLACED 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. THE CUSTOMER MAY HAVE INTERPRETED THE DEVICE FAILING TO SWITCH OFF CORRECTLY AS THE DEVICE SWITCHING ON AUTOMATICALLY AS PER THE REPORTED FAULT.IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD, AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH A SAM 350P.

    Description of Event or Problem · 0

    DEVICE SWITCHING ON AUTOMATICALLY. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICE SWITCHING ON AUTOMATICALLY. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263703 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1