BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5437875 · Received February 16, 2016

    Report

    Report Number
    3004123209-2016-00221
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    February 10, 2016
    Report Date
    April 13, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 USER FIRST ATTEMPTED TO INSTALL THE PAD-PAK ON THE 19TH JUNE 2013, THE PAD-PAK WAS SUCCESSFULLY INSTALLED A MINUTE LATER AND PASSED A SELF-TEST. THE DEVICE PERFORMED SELF-TESTS, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO AND INCLUDING THE LAST LOG ENTRY ON THE 28TH FEBRUARY 2016. A TEST PAD-PAK WAS INSERTED INTO THE DEVICE AND THE DEVICE PASSED THE SUBSEQUENT SELF-TEST. NO STATUS LED WAS VISIBLE THROUGHOUT THE POWER CYCLE. THE DEVICE POWERED OFF WITHOUT ANY WARNINGS AND THE GREEN STATUS LED REMAINED EXTINGUISHED. THIS WOULD CONFIRM THE REPORTED FAULT. AN ACCEPTABLE SHOCK WAS DELIVERED DURING THE TESTING. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO FAILURE OF THE SILVER PASTE CONNECTION ON GREEN STATUS LED. THE GREEN STATUS LED WAS TESTED DURING FINAL TEST, IT IS CONCLUDED THAT THE FAILURE WAS CAUSED AFTER THE DEVICE PASSED 'OUT QAT' ON THE 30TH APRIL 2013. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO STATUS INDICATOR ON DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94853 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1