BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 6131473 · Received November 29, 2016

    Report

    Report Number
    3004123209-2016-01735
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 2, 2016
    Report Date
    December 15, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K123881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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). 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 SUCCESSFULLY ON THE (B)(6) 2014 AND PERFORMED TO SPECIFICATION, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO THE (B)(6) 2016. BETWEEN THE (B)(6) 2016 AND THE LAST LOG ENTRY ON THE (B)(6) 2016 THE DEVICE RECORDS 7 MANUAL POWER UPS ALL UNDER ONE MINUTE DURATION. THE DEVICE POWERS UP IN ADULT MODE ON EACH OCCASION. A TEST PAD-PAK WAS INSERTED INTO THE DEVICE AND THE DEVICE WAS POWER CYCLED. THE ADULT PATIENT PROMPT WAS GIVEN AT POWER UP. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. A TEST PEDI-PAK WAS INSERTED INTO THE DEVICE AND THE DEVICE WAS POWER CYCLED. DURING THE POWER UP THE ADULT PATIENT PROMPT WAS GIVEN, THIS WOULD CONFIRM THE REPORTED FAULT. TEST THERAPY WAS CARRIED OUT AND A TEST SHOCK WAS DELIVERED. AN ACCEPTABLE MEASUREMENT WAS RECORDED FOR THE TEST SHOCK. THE DEVICE WAS DISASSEMBLED FOR INVESTIGATION. THE REED SWITCH WAS MEASURED AND THE MEASUREMENTS TAKEN INDICATE A FAULT. IT IS THEREFORE CONCLUDED THE REPORTED FAULT CAN BE ATTRIBUTED TO THE FAILURE OF THE REED SWITCH. AMERICAN HEART ASSOCIATION / EUROPEAN RESUSCITATION COUNCIL GUIDELINES INDICATE THAT IN A SITUATION WHERE A PEDI-PAK IS NOT AVAILABLE OR THAT THE USER IS UNSURE OF THE CHILD PATIENTS AGE AN ADULT PAD-PAK CAN BE USED.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. ADULT PATIENT PROMPT WITH PEDIATRIC PAK INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784140 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1