BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC, INC.

    MDR report key: 17208299 · Received June 27, 2023

    Report

    Report Number
    17208299
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 5, 2023
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NURSE PLUGGED IN ENDOVENOUS CATHETER INTO ABLATION MONITOR AND CATHETER WOULD NOT WORK. UNIT KEPT FIRING AN ERROR OF "DEVICE BROKEN". OBTAINED DIFFERENT CATHETER FROM THE SAME LOT AND DID NOT EXPERIENCE FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540968 MEDTRONIC, INC. ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC, INC. CF7-7-60 221780236

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown