BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD-PAK

    MDR report key: 7818005 · Received August 27, 2018

    Report

    Report Number
    3004123209-2018-00562
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    July 10, 2018
    Report Date
    December 17, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P16008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2016. THIS DEVICE WAS RAISED TO A COMPLAINT FOLLOWING A TECHNICAL SERVICE REQUEST (TSR 1807-005). UNDER CLINICAL REVIEW OF THIS TSR IT WAS RECOMMENDED THIS WAS ESCALATED TO A COMPLAINT TO INVESTIGATE THE LOW BATTERY MESSAGE ISSUED AT THE END OF THE SAVER EVO EVENT, AND THE ICG ACTIVITY. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. DURING THE INVESTIGATION, THE DEVICE WAS FOUND TO BE CORRECTLY MEASURING IMPEDANCE THROUGHOUT THE RANGE EVEN UNDER THE STRESS OF ELEVATED TEMPERATURE. AN IN-RANGE PATIENT IMPEDANCE WAS DETECTED DURING THE EVENT, PRIOR TO THE IMPEDANCE GOING OUT OF RANGE ON THE HIGH SIDE AND THE ¿CHECK PADS¿ MESSAGES, WHICH WOULD SUGGEST THE ELECTRODE PADS HAD INITIALLY BEEN CORRECTLY ATTACHED. IN THE ABSENCE OF THE PATIENT, THE INVESTIGATION WAS UNABLE TO DETERMINE WHY THE IMPEDANCE WENT ABOVE THE DETECTABLE RANGE. THE OUT OF RANGE IMPEDANCE AND THEREFORE THE LACK OF ACTIVITY RECORDED ON THE ICG TRACE MAY HAVE BEEN DUE TO A NUMBER OF THINGS, INCLUDING FOR EXAMPLE, THE PADS MAY HAVE BECOME DISLODGED, A PAD POSITIONING ISSUE, OR, THE PRESENCE OF HAIR OR OTHER CONTAMINANTS RESULTING IN AN INCREASED IMPEDANCE. THE USER SUBSEQUENTLY REMOVED THE PAD-PAK FROM THE DEVICE IN ORDER TO POWER IT OFF. BY DOING SO, THE DEVICE WAS UNABLE TO ENTER THE SHUTDOWN SEQUENCE AND LOGGED THE PAD PAK REMOVAL AS A LOW BATTERY IN THE USER ACCESSIBLE MEMORY LOG. THERE WAS NO AUDIO PROMPT GIVEN AT THIS TIME. THE LOW BATTERY, DISPLAYED ON SAVER EVO, WAS IDENTIFIED DURING THE POST EVENT REVIEW. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).

    Description of Event or Problem · 0

    DEVICE DISPLAYING LOW BATTERY WARNING WITH PAD-PAK ONLY 18 MONTHS OLD. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICE DISPLAYING LOW BATTERY WARNING WITH PAD-PAK ONLY 18 MONTHS OLD. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662028 HEARTSINE SAMARITAN 350P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1