BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7633058 · Received June 25, 2018

    Report

    Report Number
    3004123209-2018-00419
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    June 1, 2018
    Report Date
    October 9, 2018
    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 TECHNOLOGIES LLC (IMPORTER BEHALF OF HEARTSINE) H3 OTHER TEXT: DEVICE NOT RETURNED YET.

    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 (B)(6) 2015. ON THE (B)(6) 2018 AND THE (B)(6) 2018, INFORMATION FROM THE TECHNICAL LOG INDICATES THE SHOCK KEY HAD EITHER BEEN ¿STUCK¿ OR HELD DOWN BY AN EXTERNAL FORCE, AS THE DEVICE ALTERNATES BETWEEN FAILING AND PASSING MULTIPLE SELF-TESTS DURING MANUAL POWER UPS. THIS RESULTED IN THE DEVICE POWERING OFF WITH A FLASHING RED STATUS LED AND A ¿WARNING DEVICE SERVICE REQUIRED¿ MESSAGE ALONG WITH A FAILURE CHIRP AS PER THE REPORTED FAULT. NO FAULT COULD BE MEASURED OR OBSERVED WITH THE SHOCK KEY LINE AND SHOCK BUTTON. 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 OPERATION WITHOUT FAULT. THE FAULT WAS ONLY REPLICATED BY HOLDING IN THE SHOCK KEY DURING A SELF-TEST AT THE START OF A MANUAL POWER CYCLE. 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.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. RED STATUS INDICATOR FOLLOWING SELF TEST

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. RED STATUS INDICATOR FOLLOWING SELF TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476159 PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1