BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834863 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00016
    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

    DURING DEVICE CHECK ON (B)(6) 2024, IMD4005882 WAS FOUND TO HAVE A DEAD BATTERY. THIS WAS PROPERLY TROUBLESHOOTED AND THE PATIENT HAS BEEN SCHEDULED FOR A DEVICE SWAP ON (B)(6) 2024 AT (B)(6). THIS IS ONE OF THE 25 DEVICES THAT HAD THIS ISSUE. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER INSPECTION ON FEB. 2025. AVERTIX PERFORMED A RECALL/CORRECTION IN 2023 FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022819 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC AMSG3-E 120120V0209530000035

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown Required Intervention