BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIONET

    MDR report key: 21499316 · Received February 28, 2025

    Report

    Report Number
    3003681187-2024-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    September 3, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BIONET CO., LTD.
    Product Code
    DPS
    PMA / PMN Number
    K113306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED THE INCIDENT REPORT BUT HAVE NOT YET RECEIVED ANY INFORMATION INDICATING THAT THE INCIDENT WAS CAUSED BY THE DEVICE WE MANUFACTURED. ONCE WE RECEIVE FURTHER INFORMATION FROM THE INSURANCE COMPANY'S INVESTIGATORS, WE WILL TAKE ANY NECESSARY FOLLOW-UP ACTIONS.

    Description of Event or Problem · 0

    AS THE MANUFACTURER, WE HAVE BEEN NOTIFIED THROUGH OUR IMPORTER/DISTRIBUTOR OF A CLAIM THAT ONE OF OUR PRODUCTS MAY HAVE BEEN INVOLVED IN A FIRE INCIDENT. WE HAVE INITIATED AN INTERNAL INVESTIGATION AND ARE CURRENTLY AWAITING DETAILED ON-SITE INSPECTION REPORTS FROM THE INSURANCE COMPANY AND OUR DISTRIBUTOR TO PROCEED FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522594 BIONET ECG MACHINE DPS BIONET CO., LTD. CARDIO 7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown