BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7205293 · Received January 19, 2018

    Report

    Report Number
    3004123209-2018-00091
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    January 4, 2018
    Report Date
    April 11, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    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 SAM 300 DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED. NO REWORK WAS CONDUCTED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 23RD OCTOBER 2006. A VISUAL INSPECTION OF THE DEVICE REVEALED NO APPARENT DEFECTS. THE DEVICE RECORDED 44 LOG ENTRIES, INCLUDING MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION, BETWEEN THE 31ST JULY 2016 AND THE 5TH DECEMBER 2017. AS THE DEVICE PASSED OUT QAT ON THE 23RD OCTOBER 2006 AND THE FIRST LOG ENTRY WAS ON THE 31ST JULY 2016, THIS WOULD INDICATE THAT THE USER ACCESSIBLE MEMORY WAS ERASED PRIOR TO THE FIRST LOG ENTRY. AS THIS IS A PRE-2008 MODEL WHICH ONLY CONTAINS A USER ACCESSIBLE MEMORY LOG NO INFORMATION CAN BE DETERMINED BETWEEN THESE DATES. THE RANDOM NATURE OF THE EVENTS STORED IN THE MEMORY AND THE 10 MINUTE TIME OUTS, WOULD SUGGEST A FAILING MEMBRANE. THE REPORTED PROBLEM, OF THE DEVICE SWITCHES ON AUTOMATICALLY, WAS ATTRIBUTED TO A MEMBRANE FAILURE. THE RETURNED SAM 300 IS NOW OUTSIDE OF ITS WARRANTY PERIOD AND WILL BE SCRAPPED.

    Description of Event or Problem · 0

    DEVICE DISPLAYING SWITCHING ON AUTOMATICALLY SYMPTOM.

    Description of Event or Problem · 0

    DEVICE DISPLAYING SWITCHING ON AUTOMATICALLY SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49475 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1