BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834862 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00017
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    December 10, 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

    IMD EARLY ERI/EOS. THIS DEVICE WAS ONE OF 25 IMPACTED BY A BATTERY ISSUE. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER A FEB 2025 INSPECTION. AVERTIX PERFORMED A RECALL/CORRECTION IN 2023 FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022818 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC. AMSG3-E 112020V0203090000030

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention