BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834857 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00011
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    November 19, 2024
    Report Date
    April 12, 2025
    Manufacturer
    AVERTIX MEDICAL
    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

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THE 25 DEVICES IMPACTED BY THIS PROBLEM. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER AN INSPECITON ON FEB 19 - THRU MARCH 11, 2025. AVERTIX PERFORMED A VOLUNTARY CORRECTION IN 2023.

    Description of Event or Problem · 0

    IMD EARLY ERI/EOS. THIS IS ONE OF THE 25 DEVICES THAT HAVE EXPERIENCED PREMATURE EOS DUE TO A BATTERY PROBLEM. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER AN INSPECTION ON FEB 19 THRU MARCH 11, 2025. AVERTIX PERFORMED A VOLUNTARY FIELD CORRECTION IN 2023 REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989652 THE GUARDIAN SYSTEM THE GUARDIAN QBI AVERTIX MEDICAL AMSG3-E 120120V0209530000031

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention