BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834881 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00008
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 12, 2025
    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 A RETROACTIVE MDR FILING BASED ON A REQUEST FROM CDRH AND OII OF FDA.

    Description of Event or Problem · 0

    WENT TO PERFORM DOWNLOAD ON PATIENT AND IMD WAS NOT RESPONDING. USED BOTH SITE PROGRAMMER AND PERSONAL PROGRAMMER BOTH OF WHICH FAILED TO ESTABLISH A CONNECTION. THIS MDR IS ONE OF 25 DEVICES IMPACTED BY THIS PROBLEM. THE MDR IS BEING FILED AT THE REQUEST OF CDRH AND OII AFTER AN INSPECTION WAS PERFORMED ON FEB 19TH THRU MAR 11, 2025. AVERTIX PERFORMED A VOLUNTARY FIELD CORRECTION A COUPLE YEARS AGO FOR THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007189 THE GUARDIAN SYSTEM THE GUARDIAN QBI AVERTIX MEDICAL AMSG3-E 021721V0210150000047

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention