BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 5811503 · Received July 21, 2016

    Report

    Report Number
    3004123209-2016-00977
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    July 14, 2016
    Report Date
    July 27, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K123881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. ON RECEIPT OF THE DEVICE THE DEVICE MEMORY WAS DOWNLOADED. THE DEVICE WAS REPORTED AS BEING USED IN AN SCA EVENT ON THE 25TH JUNE 2016. THE DEVICE WAS POWERED ON AT 14.50H (GMT) AND THE DEVICE ISSUED THE APPROPRIATE VOICE PROMPTS - "ADULT PATIENT. CALL FOR MEDICAL ASSISTANCE". THE ELECTRODE PADS WERE ATTACHED TO THE PATIENT 1 MINUTE AND 34 SECONDS INTO THE EVENT. THE PATIENT'S HEART RHYTHM WAS ASSESSED AND A "NO SHOCK ADVISED" VOICE PROMPT WAS ISSUED. THE USER WAS THEN ADVISED TO BEGIN CPR. APPROXIMATELY 28 SECONDS INTO THE CPR CYCLE, THE PATIENT'S IMPEDANCE WENT OUT OF RANGE. THIS IS CONSISTENT WITH THE ELECTRODE PADS BECOMING DETACHED FROM THE PATIENT. THE USER WAS THEN PROMPTED TO "CHECK PADS" AND THIS PROMPT WAS REPEATED MORE THAN 30 TIMES BEFORE THE END OF THE EVENT. THE USER ALSO PRESSED THE ON/OFF BUTTON ON THE DEVICE ON A NUMBER OF OCCASIONS TOWARDS THE END OF THE EVENT AND ON EACH OCCASION THE DEVICE WARNED THE USER THAT THE ON/OFF BUTTON HAD BEEN PRESSED. THIS IS A FAILSAFE MECHANISM IN THE DEVICE TO WARN THE USER THAT THE ON/OFF BUTTON MAY HAVE BEEN PRESSED UNINTENTIONALLY. THE USER THEN REMOVED THE PAD-PAK FROM THE DEVICE IN ORDER TO SHUT IT DOWN. 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. NO FAULT WAS FOUND WITH THE SAM 350P DEVICE DURING THE INVESTIGATION. INVESTIGATION WAS UNABLE TO REPLICATE THE REPORTED FAULT.

    Description of Event or Problem · 0

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. THE PATIENT DIED. LOW BATTERY WARNING AND CHECK PADS PROMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466670 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death