BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK K014067

    MDR report key: 7319684 · Received March 7, 2018

    Report

    Report Number
    3004123209-2018-00201
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 1, 2018
    Report Date
    April 17, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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

    EXEMPTION NUMBER E2015058. (B)(4). 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 (B)(4) ON THE (B)(6) 2016. THE DETAILS OF COMPLAINT WERE ¿RED STATUS INDICATOR FLASHING AND BEEPING¿. THE INVESTIGATION CONCLUDED THAT THE +VE POGO PIN FAILED. HARDWARE AND SOFTWARE UPGRADES AS PER (B)(4) AND FINAL TEST ((B)(4)) WERE IMPLEMENTED. THE POGO PINS WERE REPLACED. THE SAM 300P LAST PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2016. A VISUAL INSPECTION OF THE DEVICE REVEALED NO APPARENT DEFECTS. THE DEVICE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2017 AND PERFORMED TO SPECIFICATION UP TO THE 19TH NOVEMBER 2017. THE DEVICE WAS MANUALLY POWER CYCLED ON ONE OCCASION ON THE (B)(6) 2017 FOR LESS THAN 1 MINUTE DURATION. THE PAD-PAK WAS REMOVED. ON THE (B)(6) 2018 THE PAD-PAK WAS REINSTALLED AND PASSED AN AUTO SELF-TEST THEN PASSED A MANUAL POWER ON OF UNDER 1 MINUTE DURATION. NO FURTHER LOG ENTRIES WERE RECORDED. A TEST PAD-PAK WAS INSERTED INTO THE DEVICE AND SUCCESSFULLY PASSED AN AUTO SELF-TEST THEN PASSED A SELF-TEST DURING A MANUAL POWER CYCLE. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE. THE INVESTIGATION WAS UNABLE TO REPLICATE OR FIND CONCLUSIVE EVIDENCE OF THE REPORTED FAULT. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS EQUATES TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT 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
    165577 HEARTSINE SAMARITAN 300P AND PAD-PAK K014067 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1