BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10199135 · Received June 26, 2020

    Report

    Report Number
    3004123209-2020-00152
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    July 31, 2018
    Report Date
    June 26, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE HDF-3500 DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE HDF-3500 PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 16TH NOVEMBER 2017. DURING THE INVESTIGATION TRANSISTOR Q36 WAS MEASURED AND FOUND TO HAVE FAILED. THIS HAD RESULTED IN THE GREEN STATUS INDICATOR BEING DIMLY LIT BETWEEN THE REGULAR 5 SECOND FLASHES.THE FAULT COULD NOT BE REPLICATED AFTER REPLACING Q36, EVEN AFTER STRESS TESTING. THIS WOULD INDICATE THE REPORTED FAULT WAS DUE TO A LEAKAGE CURRENT ACROSS TRANSISTOR Q36. THE DEVICE HAD PASSED HDF-3500 FINAL UNIT TEST ON THE 16TH NOVEMBER 2017, THEREFORE THE FAILURE OF Q36 WOULD HAVE OCCURRED AFTER THIS TIME. DUE TO THE STRESS TESTING CARRIED OUT IN THIS INVESTIGATION, THE DEVICE SHALL BE RETAINED AND REPLACED WITH ANOTHER HDF-3500.

    Description of Event or Problem · 1

    THE GREEN STATUS INDICATOR FLASHES EVERY 5 SECONDS WHEN STOOD UP, BUT EVERY 2 SECONDS WHEN IT IS LYING DOWN. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665863 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1