BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5540702 · Received April 1, 2016

    Report

    Report Number
    3004123209-2016-00418
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    March 23, 2016
    Report Date
    May 12, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 PAD-PAK WAS FIRST INSTALLED ON THE 19TH NOVEMBER 2012 AND HAD PERFORMED TO SPECIFICATION UP TO THE 7TH FEBRUARY 2016. ON THE 14TH FEBRUARY 2016 THE DEVICE RECORDED A CONFIGURATION ERROR WITH NONSENSICAL DURATION. INFORMATION FROM THE TECHNICAL LOG RECORDS THE FAILURE WAS DUE TO A SHOCK KEY ERROR. THE DEVICE WAS STILL IN FAULT MODE ON THE 23RD MARCH 2016 WHEN THE DEVICE WAS POWER CYCLED PASSING A SELF-TEST. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE. THE DEVICE SUCCESSFULLY PASSED A SELF-TEST DURING A MANUAL POWER CYCLE. NO WARNINGS WERE GIVEN ON SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. A SUCCESSFUL TEST SHOCK WAS DELIVERED DURING THE TESTING WITH AN ACCEPTABLE MEASUREMENT BEING RECORDED. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THIS RESULTED IN THE DEVICE DELIVERING A SHOCK WITHOUT ASSISTANCE, UPON ILLUMINATION OF THE SHOCK LAMP. THIS FAULT COULD NOT BE REPLICATED WITH A KNOWN GOOD MEMBRANE FITTED. THE MEASURABLE FAULT ON THE SHOCK KEY LIKELY LED TO THE MULTIPLE SELF-TEST FAILS.

    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

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PAD UNIT HAS RED STATUS INDICATOR LIGHT INDICATING A FAULT HAD BEEN DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197706 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1