BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5352973 · Received January 8, 2016

    Report

    Report Number
    3004123209-2015-01697
    Event Type
    Death
    Date Received
    January 8, 2016
    Date of Event
    December 12, 2015
    Report Date
    February 3, 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
    PA, US
    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 8TH MARCH 2007. HEARTSINE TECHNOLOGIES LTD EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CAUSE WAS DETERMINED TO BE DUE TO FAILURE OF COMPONENT U23 ON THE PCB ASSEMBLY. THE FAILED COMPONENT IS IN THE PATIENT IMPEDANCE MEASURING CIRCUIT.

    Description of Event or Problem · 0

    DEVICE WAS USED IN A SUDDEN CARDIAC ARREST EVENT WHERE THE PATIENT DIED. THE DEVICE DID NOT GO PAST THE PLACE PADS PROMPT AND REPEATEDLY TOLD THE USER TO PLACE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14304 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death