BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5384798 · Received January 22, 2016

    Report

    Report Number
    3004123209-2016-00066
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    January 14, 2016
    Report Date
    March 11, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 FIRST MEMORY LOG ENTRY RECORDED WAS (B)(6) 2010, 8 FURTHER MANUAL POWER UPS WERE RECORDED UP TO (B)(6) 2013. A MANUAL POWER UP OF 45 MINUTES WAS RECORDED ON (B)(6) 2013, A PATIENT IMPEDANCE WAS MEASURED DURING THIS TIME, WITH THREE TEST SHOCKS BEING DELIVERED. THE DEVICE MEMORY WOULD HAVE BECOME FULL DURING THIS TIME. A FURTHER 8 MANUAL POWER UPS WERE RECORDED UP TO (B)(6) 2015, ONE OF TEN MINUTES DURATION. INVESTIGATION WAS UNABLE TO REPLICATE THE REPORTED FAULT. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. THE POWER UPS SUGGEST THE USER MAY HAVE BEEN MANUALLY POWER CYCLING THE DEVICE OR THE BEGINNINGS OF MEMBRANE FAILURE. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43706 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1