BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10384577 · Received August 10, 2020

    Report

    Report Number
    3004123209-2020-00255
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 10, 2020
    Report Date
    October 19, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 5TH APRIL 2017. DURING THE INVESTIGATION, THE FAILURE OF MOSFET Q45 WAS CONFIRMED BY MEASUREMENT. THIS HAD CAUSED THE RTC INTERRUPT TO BE DRAGGED LOW DESPITE FAILING NO SELF-TEST, RESULTING IN A FLASHING RED STATUS LED, AS PER THE REPORTED FAULT. ADDITIONALLY, WHILE THIS INTERRUPT IS LOW, THE DEVICE WOULD NOT PERFORM AUTO SELF-TESTS. THIS BEHAVIOUR WAS WITNESSED DURING THE INVESTIGATION. THE PCBA WILL BE RETURNED TO THE Q45 COMPONENT MANUFACTURER, DIODES INC, FOR ANALYSIS. IT IS A POLICY OF HEARTSINE TO NOT REFURBISH DEVICES THAT HAVE BEEN RETURNED FROM THE FIELD, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH A NEW HDF-3500.

    Description of Event or Problem · 0

    THE RED LIGHT IS BLINKING.THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE RED LIGHT IS BLINKING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853251 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1