BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10

    MDR report key: 8001848 · Received October 24, 2018

    Report

    Report Number
    3004123209-2018-00679
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    October 1, 2018
    Report Date
    March 11, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 500P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 500P PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE 4TH JUNE 2015. ON THE 24TH SEPTEMBER 2018 THE DEVICE RECORDS 21 MANUAL POWER ONS. SEVEN OF THE POWER ONS RECORD A FAILED SELF-TEST. INFORMATION FROM THE TECHNICAL LOG SHOWS THAT ALL SEVEN FAILED SELF-TESTS HAD THE SHOCK BUTTON PRESSED WHILE THE DEVICE WAS POWERED ON RESULTING IN THE DEVICE FAILING SELF-TESTS DUE TO A SHOCK KEY ERROR. THE FAULT WAS REPLICATED BY HOLDING THE SHOCK BUTTON PRIOR TO POWERING ON THE DEVICE. THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING DEVICE SERVICE REQUIRED¿ PROMPT AND A RED STATUS LED. NO FAULT COULD BE MEASURED OR OBSERVED WITH THE SHOCK KEY LINE. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS EQUATES TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT FAULT. THE SHOCK KEY ERRORS DETAILED IN THE HISTORY LOG CORRESPOND WITH THE SHOCK TESTING CARRIED OUT BY "BIOMEDICAL SOLUTIONS" ON THE 24TH SEPTEMBER 2018. THEREFORE, IT IS REASONABLE TO ASSUME THAT THE FAULT WITNESSED WAS DUE TO THE SHOCK TESTING THAT HAD TAKEN PLACE ON THIS DATE. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD, AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH ANOTHER DEVICE OF THE SAME MODEL. IT WAS ALSO IDENTIFIED THAT THE USER MANUAL STATES ¿OUR DEVICES CANNOT BE TESTED USING INDUSTRY-STANDARD SIMULATORS AND MANIKINS¿ AND THAT THE DEVICE ¿CONTAINS NO USER SERVICEABLE PARTS, THEREFORE AN ANNUAL SERVICE IS NOT REQUIRED¿.

    Description of Event or Problem · 0

    DEVICE SERVICE REQUIRED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    DEVICE SERVICE REQUIRED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843532 PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1