BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD PAK

    MDR report key: 6840886 · Received September 4, 2017

    Report

    Report Number
    3004123209-2017-00975
    Event Type
    Malfunction
    Date Received
    September 4, 2017
    Date of Event
    August 18, 2017
    Report Date
    October 19, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 DEVICE HISTORY RECORDS FOR THE RETURNED SAM 500P DEVICE WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 500P FROM HEARTSINE TECHNOLOGIES, BELFAST ON 27TH JANUARY 2015. 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 ON (B)(6) 2015 AND PERFORMED TO SPECIFICATION UP UNTIL (B)(6) 2017. THE USER ACCESSIBLE MEMORY WAS ERASED ON (B)(6) 2017. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR ANALYSER AND DELIVERED A TEST SHOCK WITHOUT FAULT. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE AND NO DEFECTS WERE FOUND. THE DEVICE LANGUAGE WAS CHANGED TO US ENGLISH. THE LANGUAGE CHANGE WAS SUCCESSFUL AND ALL VOICE PROMPTS WERE GIVEN AS EXPECTED. THIS INDICATES AN ISSUE HAD DEVELOPED WITH THE DIGITAL SPEECH CHIP. THE FAULT WAS REPLICATED BY BEGINNING A LANGUAGE CHANGE THEN IMMEDIATELY REMOVING THE USB CABLE DURING THE SPEECH ERASE SEQUENCE. THE DEVICE WAS THEN POWER CYCLED WITH NO AUDIO PROMPTS. THIS SUGGESTS A FAILED LANGUAGE CHANGE RESULTED IN THE REPORTED FAULT. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620920 HEARTSINE SAMARITAN 500P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1