BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6881868 · Received September 21, 2017

    Report

    Report Number
    3004123209-2017-01020
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 30, 2017
    Report Date
    October 19, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 360P DEVICE WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DISPATCH OF THE SAM 360P FROM HEARTSINE TECHNOLOGIES, BELFAST ON 19TH APRIL 2013. ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2013 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2016. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR ANALYSER AND DELIVERED A TEST SHOCK WITHOUT FAULT. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE. THE TOP LAYERS OF THE MEMBRANE WERE THEN PEELED BACK TO VISUALLY INSPECT THE TRACKS WITHIN THE MEMBRANE. EVIDENCE OF CORROSION WAS OBSERVED ON THE ON/OFF BUTTON AND SHOCK KEY. THIS WOULD INDICATE THE DEVICE HAD BEEN SUBJECT TO MOISTURE INGRESS.

    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. DEVICE OBSERVED SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663330 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1