BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5494357 · Received March 11, 2016

    Report

    Report Number
    3004123209-2016-00297
    Event Type
    Malfunction
    Date Received
    March 11, 2016
    Date of Event
    February 21, 2016
    Report Date
    April 13, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). ON RECEIPT OF THE DEVICE THE DEVICE MEMORY WAS DOWNLOADED. THE DEVICE WAS REPORTED AS BEING USED IN AN SCA EVENT ON (B)(6) 2016. DURING THE EVENT THE DEVICE WAS MANUALLY POWERED UP ON THREE OCCASIONS. ON THE FIRST MANUAL POWER, UP AN "IN RANGE" PATIENT IMPEDANCE WAS DETECTED. A SHOCK WAS ADVISED AND DELIVERED APPROXIMATELY 15 SECONDS INTO THE EVENT. AFTER A TWO-MINUTE PERIOD OF CPR, THE PATIENT'S HEART RHYTHM WAS AGAIN ASSESSED. A SHOCKABLE RHYTHM WAS INITIALLY DETECTED HOWEVER THE RHYTHM WAS THEN REASSESSED AS NON-SHOCKABLE. THE SHOCK BUTTON WAS PRESSED TWICE DURING THIS TIME, BUT DUE TO THE RE-ASSESSMENT OF THE PATIENT'S HEART RHYTHM, THE SHOCK BUTTON WAS NOT ACTIVATED AND NO SHOCK WAS DELIVERED. AFTER THE RE-ASSESSMENT THE USER WAS ISSUED WITH THE "NO SHOCK ADVISED" VOICE PROMPT. A FURTHER TWO-MINUTE PERIOD OF CPR WAS ADMINISTERED TO THE PATIENT AND AFTER THIS, ANOTHER ASSESSMENT OF THE PATIENT'S HEART RHYTHM WAS CARRIED OUT BY THE DEVICE. INITIALLY THE RHYTHM WAS ASSESSED AS "SHOCKABLE" BUT A FURTHER ASSESSMENT CHANGED THIS ASSESSMENT TO "NON-SHOCKABLE". THE USER THEN CONTINUED TO PERFORM CPR ON THE PATIENT UP UNTIL THE ELECTRODES WERE REMOVED, AFTER WHICH THE DEVICE WAS POWERED OFF. DURING THE ENGINEERING INVESTIGATION THE DEVICE WAS FULLY TESTED AND PERFORMED TO SPECIFICATION. THE ENGINEERING INVESTIGATION FOUND NO FAULT WITH THE RETURNED DEVICE. THE PERFORMANCE OF THE DEVICE WAS ADVERSELY AFFECTED BY THE USER CONTINUING TO PERFORM CPR DURING THE ANALYSIS PERIOD AND ALSO BECAUSE THE SOFTWARE IN THE DEVICE HAD NOT BEEN UPDATED TO THE LATEST AVAILABLE VERSION.

    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

    Description of Event or Problem · 0

    THERE WAS A PATIENT INVOLVED IN THIS EVENT. THE PATIENT DIED. NO SECOND SHOCK GIVEN ALTHOUGH ADVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152633 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death