BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD PAK

    MDR report key: 5009527 · Received August 18, 2015

    Report

    Report Number
    3004123209-2015-00850
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    June 14, 2015
    Report Date
    August 12, 2015
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2012 AND THAT IT PERFORMED SUCCESSFUL WEEKLY AUTO SELF-TESTS UP TO (B)(6) 2015. THE DEVICE WAS REPORTED AS BEING USED IN AN SCA EVENT LATER ON (B)(6) 2015 AND WAS POWERED UP ON THREE OCCASIONS. THERE WAS NO INFORMATION RELATING TO THE REPORTED SCA PRESENT ON THE RETURNED SAM 500P AS THE USER ACCESSIBLE MEMORY LOG HAD BEEN ERASED PRIOR TO RECEIPT AT HEARTSINE. HOWEVER THE USER DID RETURN A DOWNLOAD. THE DEVICE WAS POWERED ON AT 14:43:16H (GMT), ON (B)(6) 2015. THE SHOCK BUTTON WAS DETECTED AS BEING PRESSED IMMEDIATELY ON POWER UP, THE DEVICE THEN POWERED OFF WITH A DEVICE SERVICE REQUIRED PROMPT. THE DEVICE WAS POWERED ON AGAIN, SHORTLY AFTER THIS, AT 14:43:41H (GMT). THE USER WAS ISSUED WITH THE ADVISORY SPEECH PROMPTS OF "ADULT PATIENT, CALL FOR MEDICAL ASSISTANCE" THE DEVICE WAS THEN POWERED OFF VIA THE ON/OFF BUTTON APPROXIMATELY 24 SECONDS INTO THE EVENT. THE THIRD POWER ON OCCURRED AT 14:45:27H (GMT). THE DEVICE POWERED ON WITH "ADULT PATIENT, ASSESSING HEART RHYTHM" THIS WOULD INDICATE THAT THE ELECTRODE PADS HAD ALREADY BEEN ATTACHED TO THE PATIENT PRIOR TO THE DEVICE BEING POWERED ON. THE HEART RHYTHM WAS ASSESSED AND "NO SHOCK ADVISED" WAS PROMPTED. THE USER WAS THEN ADVISED TO "BEGIN CPR". THE DEVICE WAS THEN POWERED OFF VIA THE ON/OFF BUTTON, 51 SECONDS INTO THE EVENT. THERE WERE NO FURTHER HISTORY LOG ENTRIES. THE SAM 500P PERFORMED AS EXPECTED DURING THE REPORTED SCA EVENT. A POTENTIAL USER ERROR RESULTED IN THE REPORTED FAILURE. THE DEVICE HAD SUCCESSFULLY PERFORMED WEEKLY AUTO SELF-TESTS FROM INITIAL INSTALLATION UP TO AND INCLUDING THE SELF-TEST ON THE DAY OF THE REPORTED SCA ON (B)(6) 2015. THE DEVICE WAS THEN MANUALLY POWERED UP ON THREE OCCASIONS DURING THE SCA EVENT. ON THE FIRST POWER UP, THE DEVICE RECORDS THE SHOCK BUTTON BEING PRESSED IMMEDIATELY PRIOR TO ANY SPEECH PROMPTS BEING ISSUED. THIS RESULTED IN THE DEVICE POWERING OFF WITH A "WARNING, DEVICE SERVICE REQUIRED" PROMPT, AND AN ERROR - SHOCK KEY STUCK MESSAGE DISPLAYED IN THE SAVER EVO APPLICATION. THE MEMBRANE WAS INSPECTED AND NO VISIBLE FAULT COULD BE FOUND WITH THE SHOCK BUTTON. THE EFFECT OF PRESSING THE SHOCK BUTTON IMMEDIATELY AFTER THE DEVICE WAS SWITCHED ON WAS REPLICATED DURING TESTING AT HEARTSINE. THE DEVICE WAS THEN POWERED ON FOR A SECOND TIME WITH THE USER BEING ISSUED WITH THE ADVISORY SPEECH PROMPT BEFORE THE DEVICE WAS TURNED OFF VIA THE ON/OFF BUTTON. THE FINAL POWER UP DETECTED A PATIENT IMPEDANCE, ASSESSED THE HEART RHYTHM AND THEN PROMPTED "NO SHOCK ADVISED". THE DEVICE WAS STRESSED TESTED AT 50°C FOR 24 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES WITH NO FAULT FOUND. THE INVESTIGATION THEREFORE CONCLUDES THAT THE USER HAD INCORRECTLY PRESSED THE SHOCK BUTTON, DURING THE FIRST POWER ON. THIS IS FURTHER SUPPORTED BY THE SUBSEQUENT POWER ONS DISPLAYING NO FAULT.

    Description of Event or Problem · 1

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. ERROR MESSAGE PROMPT REGARDING SHOCK BUTTON STUCK DURING CUSTOMER EVENT. PATIENT SURVIVED TO HOSPITAL DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543829 HEARTSINE SAMARITAN 500P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR