BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10199103 · Received June 26, 2020

    Report

    Report Number
    3004123209-2020-00151
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    July 30, 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 1ST FEBRUARY 2018. THE RETURNED HDF-3500 WAS WITNESSED SWITCHING ON AUTOMATICALLY DURING INVESTIGATION, WHICH CONFIRMED THE REPORTED FAULT. THE INVESTIGATION REVEALED A PARTIAL SOLDER SHORT CIRCUIT ACROSS TRANSISTOR Q38. THIS TRANSISTOR FORMS PART OF THE ON/OFF CIRCUITRY AND WILL POWER ON THE DEVICE WHEN THE ON/OFF BUTTON IS PRESSED. AS CURRENT SHOULD ONLY FLOW THROUGH Q38 WHEN THE ON/OFF BUTTON IS PRESSED, THE PARTIAL SHORT CIRCUIT HAD CAUSED THE DEVICE TO INTERMITTENTLY SWITCH ITSELF ON. THE FAULT COULD NOT BE REPLICATED FOLLOWING REMOVAL OF THE SOLDER SHORT. 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

    DEVICE SWITCHED ON AUTOMATICALLY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664855 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1