BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7457386 · Received April 25, 2018

    Report

    Report Number
    3004123209-2018-00284
    Event Type
    Death
    Date Received
    April 25, 2018
    Date of Event
    March 26, 2018
    Report Date
    June 27, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC (IMPORTER BEHALF OF HEARTSINE H3 OTHER TEXT: NOT RETURNED YET.

    Description of Event or Problem · 0

    THIS WAS A PATIENT INVOLVED EVENT . THE DEVICE WAS USED BY THE POLICE IN (B)(6) DURING A SCA. THE DEVICE PROMPTED TO SHOCK TWICE HOWEVER NO SHOCK WAS DELIVERED ON PRESSING THE SHOCK BUTTON AND THE DEVICE SWITCHED OFF. A SECOND AED FROM ANOTHER FIRST RESPONDER WAS USED IN SUBSTITUTION AND SUBSEQUENTLY DELIVERED 2 X SHOCKS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. NO REWORK WAS CONDUCTED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 11TH JULY 2013. THERE WAS NO ECG/ICG DATA TO REVIEW REGARDING THE REPORTED PATIENT INVOLVED EVENT ON THE (B)(6) 2018 AS THE DEVICE MEMORY HAD BECOME FULL. THE INVESTIGATION WAS THEREFORE UNABLE TO DETERMINE THE PATIENT¿S PRESENTING HEART RHYTHM. THE SAM 300P WILL ABORT A READY TO SHOCK CONDITION ONCE A NON-SHOCKABLE RHYTHM IS DETECTED, AND BASED ON THE INFORMATION AVAILABLE, THIS APPEARS TO HAVE BEEN THE CASE ON THREE OCCASIONS. FURTHERMORE, THE DEVICE WAS CORRECTLY SHUTDOWN, BY THE USER, ON TWO OCCASIONS DURING THE REPORTED EVENT WITH A ¿WARNING MEMORY FULL¿ AUDIO PROMPT BEING ISSUED. THE DEVICE HAD BEEN PREVIOUSLY USED DURING PATIENT INVOLVED EVENTS ON A NUMBER OF OCCASIONS THROUGHOUT THE PERIOD OF INSTALLATION WITH NO APPARENT ISSUE. THE PATIENT INVOLVED EVENT PRIOR TO THIS ONE, ON THE (B)(6) 2017, DID DELIVER TWO SHOCKS. THESE MULTIPLE EVENTS HAD RESULTED IN THE DEVICE MEMORY BECOMING FULL ON THE (B)(6) 2015. THE INVESTIGATION TESTED THE DEVICES¿ ABILITY TO DELIVER THE SHOCK THERAPY SEQUENCE AND NO FAULT WAS FOUND. A VISUAL INSPECTION OF THE PCBA IDENTIFIED NO ABNORMALITIES. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).

    Description of Event or Problem · 1

    THIS WAS A PATIENT INVOLVED EVENT . THE DEVICE WAS USED BY THE POLICE IN (B)(6) DURING A SCA. THE DEVICE PROMPTED TO SHOCK TWICE HOWEVER NO SHOCK WAS DELIVERED ON PRESSING THE SHOCK BUTTON AND THE DEVICE SWITCHED OFF. A SECOND AED FROM ANOTHER FIRST RESPONDER WAS USED IN SUBSTITUTION AND SUBSEQUENTLY DELIVERED 2 X SHOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305359 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death