BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834872 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00026
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    May 13, 2024
    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

    Additional Manufacturer Narrative · 0

    PATIENT DIAGNOSED WITH LUNG CANCER - NO EXPLANT OF DEVICE PLANNED.

    Description of Event or Problem · 0

    PREMATURE BATTERY DEPLETION. THIS DEVICE WAS ONE OF 25 DEVICES THAT HAD PREMATURE BATTERY DEPLETION. THIS MDR IS BEING FILED RETROACTIVELY AT TEH REQUEST OF CDRH AND OII AFTER AN INSPECTION IN FEB OF 2025. AVERTIX PERFORMED A RECALL/CORRECTION IN 2023 FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022828 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC. AMSG3-E 011221V0210150000039

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention