BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 6572062 · Received May 17, 2017

    Report

    Report Number
    3004123209-2017-00468
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 26, 2017
    Report Date
    June 8, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 DEVICE HISTORY RECORDS FOR THE RETURNED SAM 350P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 350P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE 15TH DECEMBER 2016. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE 28TH MARCH 2017 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO THE 9TH APRIL 2017. THE DEVICE MEMORY WAS DOWNLOADED AND INFORMATION FROM THE LOGS SUGGESTED THE DEVICE WAS RECORDING VOLTAGES SIGNIFICANTLY LOWER THAN THEY WERE MEASURED. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE. A FAULTY COMPONENT HAD CAUSED AN INCREASED CURRENT DRAIN. THIS RESULTED IN THE DEVICE RECORDING MULTIPLE SELF-TEST FAILURES DUE TO LOW BATTERY. THE USER WOULD HAVE BEEN ALERTED TO THE FAULT WITH A "WARNING LOW BATTERY, DEVICE SERVICE REQUIRED" PROMPT AND A FLASHING RED STATUS LED ALONG WITH AN AUDIBLE BEEP. AFTER REPLACING THIS COMPONENT, THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0°C AND 50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS IS EQUIVALENT TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT 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.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE BEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354295 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1