BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10223019 · Received July 2, 2020

    Report

    Report Number
    3004123209-2020-00166
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    July 1, 2018
    Report Date
    July 2, 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 HDF-3500 PASSED FINAL UNIT TEST AND OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 10TH MAY 2018. HDF-3500 DEVICES ARE SUBJECT TO OMRON GOODS INWARD TESTING AS DETAILED IN H045-014-005, OMRON GOODS INWARDS TEST PROCEDURE. THE REPORTED COMPLAINT OUTLINES THAT DURING THIS TESTING ALL THE LEDS LIT UP. INFORMATION FROM THE RETURNED OMRON TEST SHEET INDICATES THAT OMRON TESTING WAS CARRIED OUT ON THE 25TH JUNE 2018. THE DEVICE FAILED OMRON GOODS INWARD TEST PROCEDURE, H045-014-005, FOR ALL THE LEDS LIGHTING UP. ADDITIONALLY, DURING THE INVESTIGATION IT WAS FOUND THE DEVICE HAD FAILED TO POWER ON CORRECTLY OR CONNECT TO THE PC VIA USB. AFTER EXTENSIVE INVESTIGATION, THE FAULT WAS TRACED BACK TO AN INCREASED RESISTANCE ACROSS A PCBA TRACK, ADDRESS LINE A3. THIS TRACK IS A COMMUNICATION LINE BETWEEN THE MICROPROCESSOR, U25 AND THE FLASH MEMORY CHIP, U26. FAILURE OF THIS TRACK HAD RESULTED IN THE MICROPROCESSOR BEING UNABLE TO ACCESS THE STARTUP VECTORS STORED IN THE EMBEDDED SOFTWARE IN THE FLASH MEMORY AND THE DEVICE FAILING TO BOOT UP. THE DEVICE SUCCESSFULLY PASSED OUT QAT AT HEARTSINE ON THE 10TH MAY 2018, THE TRACK WOULD HAVE BEEN MAKING SUFFICIENT CONNECTION AT THIS TIME. THE FAULTY TRACK ON THE PCBA WAS LIKELY DUE TO A MANUFACTURING DEFECT WHICH HAD DETERIORATED FOLLOWING OVER TIME RESULTING IN A LATENT FAILURE. THIS DEVICE WILL BE RETAINED BY HEARTSINE AND REPLACED WITH A NEW HDF-3500.

    Description of Event or Problem · 1

    ALL THE DEVICESLEDS LIGHT UP. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688703 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1