BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5382709 · Received January 21, 2016

    Report

    Report Number
    3004123209-2016-00075
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    January 15, 2016
    Report Date
    June 8, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    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). 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 HISTORY LOGS FOR THIS DEVICE SHOWED THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 22ND NOVEMBER 2012 AND PERFORMED TO SPECIFICATION UP TO AND INCLUDING THE LAST LOG ENTRY ON THE 24TH APRIL 2016. A TEST PAD-PAK WAS INSTALLED AND THE DEVICE PASSED A SELF-TEST. NO WARNINGS WERE GIVEN AT SHUT DOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. THE DEVICE WAS TESTED ON CALIBRATED EQUIPMENT AND DELIVERED A TEST SHOCK WITHOUT FAULT. AN ACCEPTABLE MEASUREMENT WAS RECORDED. THE STAND CLEAR LEDS DID NOT ILLUMINATE DURING THE POWER UP. THE DEVICE POWERED OFF WITHOUT ANY WARNINGS AND A FLASHING GREEN STATUS LED. THIS WOULD CONFIRM THE REPORTED FAULT. INVESTIGATION FOUND THE FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE DUE TO A BROKEN TRACK. THIS RESULTED IN THE STAND CLEAR LEDS BEING EXTINGUISHED. THE STAND CLEAR LEDS FAILED TO ILLUMINATE DURING THE INVESTIGATION. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THE INSTRUCTIONAL LEDS ALONG WITH THE FUNCTION OF THE MEMBRANE WERE TESTED AS PART OF FINAL TEST AND WOULD INDICATE THE FAULT OCCURRED AFTER DISPATCH FROM HEARTSINE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. STAND CLEAR ICON ON DEVICE NOT LIGHTING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42702 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1