BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDF3500 AND PAD-PAK

    MDR report key: 10199099 · Received June 26, 2020

    Report

    Report Number
    3004123209-2020-00149
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    August 1, 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 WAS 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 10TH JUNE 2018. DURING THE INVESTIGATION, THE GREEN STATUS LED WAS FLASHING GREEN ALONGSIDE A FAILURE CHIRP, AS PER THE REPORTED FAULT. THE RED STATUS LED ON THE MEMBRANE WAS MEASURED AND FOUND TO HAVE FAILED. THIS HAD RESULTED IN A LEAKAGE CURRENT TO BEEPER BP1. THE FAULT COULD NOT BE REPLICATED WITH THE RED STATUS LED DETACHED FROM THE MEMBRANE. THIS WOULD CONFIRM THE REPORTED FAULT HAD BEEN CAUSED BY THE FAILURE OF THE RED STATUS LED. THE DEVICE WAS SUBJECT TO HDF-3500 FINAL UNIT TEST (H045-014-004) AT HEARTSINE ON THE 10TH JUNE 2018 ¿ DURING THIS TESTING, NO FAULT WAS FOUND ON THE UNIT. THIS WOULD THEREFORE INDICATE THE MEMBRANE HAD FAILED AFTER THIS DATE. IT IS A POLICY OF HEARTSINE TO NOT REFURBISH DEVICES THAT HAVE BEEN RETURNED FROM THE FIELD, THEREFORE THIS DEVICE SHALL BE RETAINED AND REPLACED WITH A NEW HDF-3500.

    Description of Event or Problem · 1

    DEVICE HAS BEEPING SOUND. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664852 HDF3500 AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1