BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5938677 · Received September 9, 2016

    Report

    Report Number
    3004123209-2016-01198
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Date of Event
    August 22, 2016
    Report Date
    October 17, 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). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. THE HISTORY LOG SHOWED THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 7TH JANUARY 2013 AND PERFORMED TO SPECIFICATION UP TO THE 19TH JULY 2015. THE PAD-PAK WAS REMOVED AND REINSTALLED ON THE 11TH AUGUST 2016 WITH THE DEVICE PASSING A SELF-TEST. THE DEVICE WAS SHIPPED FROM HEARTSINE ON THE 2ND NOVEMBER 2011 WITH 3.2.0 SOFTWARE INSTALLED AND UPON RECEIPT OF THE RETURNED DEVICE THE SOFTWARE REMAINED UNCHANGED. NO FURTHER LOG ENTRIES WERE RECORDED PRIOR TO RECEIPT AT HEARTSINE. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE AND THE DEVICE PASSED A SELF-TEST. THE DEVICE DELIVERED A TEST SHOCK WITHOUT FAULT AND AN ACCEPTABLE MEASUREMENT WAS RECORDED FOR THE SHOCK. INVESTIGATION FOUND NO FAULT WITH THE RETURNED DEVICE. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT THE HISTORY LOG AND DURING TESTING AT HEARTSINE. THE PAD 300P UPGRADER CAN ONLY BE USED TO UPGRADE THE DEVICE SOFTWARE TO 3.2.0, IF A USER ATTEMPTS TO UPGRADE A DEVICE THAT ALREADY HAS 3.2.0 SOFTWARE INSTALLED A POP UP WINDOW INFORMING THE USER THAT THE DEVICE ALREADY HAS 3.2.0 SOFTWARE INSTALLED WILL SUBSEQUENTLY BE DISPLAYED. AS THIS IS A 2011 DEVICE IT IS NOT COVERED BY THE FSCA AND THERE IS NO REQUIREMENT TO UPDATE THE SOFTWARE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. END USER HAS ATTEMPTED TO INSTALL FSCA SOFTWARE UPGRADE TO A NON FSCA UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592738 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1