BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    UNKNOWN_MEDICAL - BELFAST_PRODUCT

    MDR report key: 11364379 · Received February 23, 2021

    Report

    Report Number
    3004123209-2021-00041
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    September 25, 2020
    Report Date
    February 23, 2021
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 REVIEW REVEALED NO REWORK WAS CONDUCTED AND NO CONCESSIONS/DEVIATIONS RELATED TO THE ISSUE WERE IDENTIFIED. THE HDF-3500 PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 5TH APRIL 2017. A VISUAL INSPECTION OF THE DEVICE REVEALED NO APPARENT DEFECTS. FURTHER INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED FAULT. 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 · 1

    NO STATUS INDICATOR. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260952 UNKNOWN_MEDICAL - BELFAST_PRODUCT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1