BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834865 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00020
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    August 21, 2024
    Report Date
    April 14, 2025
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    PMA / PMN Number
    P150009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PREMATURE BATTERY EOS. THIS IS ONE OF 25 DEVICES THAT EXPERIENCED THIS PROBLEM. THIS MDR IS BEING RETROACTIVELY FILED AT THE REQUEST OF CDRH AND OII AFTER AN INSPECTION ON FEB. 2025. AVERTIX PERFORMED A RECALL/CORRECTION FOR THIS ISSUE IN 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022821 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC. AMSG3-E 120120V0209530000035

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention