BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5418829 · Received February 9, 2016

    Report

    Report Number
    3004123209-2016-00184
    Event Type
    Death
    Date Received
    February 9, 2016
    Date of Event
    January 15, 2016
    Report Date
    February 16, 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
    EI
    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. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 300P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, (B)(4) ON THE 29TH JULY 2006. HEARTSINE TECHNOLOGIES LTD EVALUATED THE RETURNED DEVICE AND WERE UNABLE TO FIND ANY MALFUNCTION. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT THE ENGINEERING INVESTIGATION. HOWEVER AN INSPECTION OF THE RETURNED PAD-PAK FOUND DAMAGE WHICH WOULD HAVE PREVENTED THE PAD-PAK FROM MAKING FULL CONTACT WITH THE DEVICE. THE REPORTED FAULT MAY HAVE BEEN CAUSED BY POORLY PLACED ELECTRODES OR AN INCORRECTLY INSTALLED PAD-PAK.

    Description of Event or Problem · 0

    PATIENT INVOLVED. DEVICE KEPT PROMPTING APPLY PADS, WOULD NOT SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79064 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death