BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10199101 · Received June 26, 2020

    Report

    Report Number
    3004123209-2020-00148
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    July 2, 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 (B)(6) 2017. DURING THE INVESTIGATION TRANSISTOR Q45 WAS MEASURED AND FOUND TO HAVE FAILED. THIS HAD RESULTED IN THE RED STATUS LED ILLUMINATING INCORRECTLY AS PER THE REPORTED FAULT. THE FAULT WAS WITNESSED DURING THE INVESTIGATION. THE FAULTS COULD NOT BE REPLICATED WHEN Q45 WAS REPLACED. DUE TO THE STRESS TESTING CARRIED OUT DURING THE INVESTIGATION, THIS DEVICE SHALL BE RETAINED AND REPLACED WITH ANOTHER HDF-3500.

    Description of Event or Problem · 1

    THE DEVIICE HAD RED AND GREEN STATUS LEDS FLICKERING. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664854 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1