BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6867895 · Received September 15, 2017

    Report

    Report Number
    3004123209-2017-01121
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    September 5, 2017
    Report Date
    October 26, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 300P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE 13TH JUNE 2011. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2011 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2017. ON (B)(6) 2017, THE DEVICE WAS REPORTED AS BEING USED IN AN SCA EVENT. DURING THE INVESTIGATION, THE ELECTRODE PADS WERE REMOVED AND REPLACED WITH TEST PLUGS. THE DEVICE WAS TESTED ON THE CALIBRATED DEFIBRILLATOR AND DELIVERED A TEST SHOCK WITHOUT FAULT. THE DEVICE POWERED OFF WITH NO WARNINGS GIVEN AND A FLASHING GREEN STATUS LED. THE ELECTRODE PADS WERE DETECTED AS BEING ATTACHED APPROXIMATELY 1 MINUTE AND 57 SECONDS INTO THE EVENT. THERE WERE SEVERAL OCCASIONS DURING THE EVENT WHEN THE PATIENT'S IMPEDANCE WENT IN AND OUT OF RANGE THE DEVICES ABILITY TO MEASURE MULTIPLE IMPEDANCES ACCURATELY WAS TESTED DURING THE INVESTIGATION WITH NO FAULT FOUND. AN IN-RANGE PATIENT IMPEDANCE WAS DETECTED PRIOR TO THE "CHECK PADS" MESSAGE, WHICH WOULD SUGGEST THE ELECTRODE PADS HAD INITIALLY BEEN CORRECTLY ATTACHED. THE VARIATION IN PATIENT IMPEDANCE MAY HAVE BEEN CAUSED BY PAD POSITIONING OR THE PRESENCE OF CONDUCTIVE MATERIAL. THE ELECTRODE PADS WOULD NEED TO MAKE A DIRECT GEL TO GEL CONTACT OR HAVE AN ALTERNATIVE CONDUCTIVE COMPONENT IN-LINE, IN ORDER TO ACHIEVE AN IMPEDANCE BELOW 20[?]. THEREFORE, IN THE ABSENCE OF THE PATIENT, THE INVESTIGATION IS UNABLE TO REPLICATE THE REPORTED FAULT.

    Description of Event or Problem · 0

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. THE DEVICE HAD A FAULT MESSAGE DURING USAGE. APPLY PADS PROMPT DURING EVENT. THE PATIENT DID NOT SURVIVE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650759 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death