BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6735553 · Received July 24, 2017

    Report

    Report Number
    3004123209-2017-00713
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    July 3, 2017
    Report Date
    February 13, 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
    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).

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. RED STATUS INDICATOR FLASHING.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2015058. (B)(4). AS THIS IS A PRE-2008 MODEL WHICH ONLY CONTAINS A USER ACCESSIBLE MEMORY LOG, NO INFORMATION CAN BE DETERMINED BETWEEN THE DEVICE PASSED 'OUT QAT' ON 31ST JANUARY 2007 AND UPON RECEIPT AT HEARTSINE. THE DEVICE RECORDS 16 MANUAL POWER UPS BETWEEN THE (B)(6) 2010 AND THE (B)(6) 2017, THE LONGEST OF WHICH LAST 28 SECONDS IN DURATION. NO FURTHER LOG ENTRIES WERE RECORDED. AS THE DEVICE PASSED OUT QAT ON THE 31ST JANUARY 2007 AND THE FIRST LOG ENTRY WAS ON THE (B)(6) 2010, 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 DEVICE WAS DISASSEMBLED FOR FURTHER INVESTIGATION. THE INVESTIGATION WAS UNABLE TO REPLICATE, OR FIND ANY CONCLUSIVE EVIDENCE, OF THE REPORTED FAULT. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519272 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1