BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALFLOW CONSOLE

    MDR report key: 23356239 · Received October 22, 2025

    Report

    Report Number
    3011468686-2025-00094
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    April 2, 2025
    Report Date
    October 22, 2025
    Manufacturer
    MC3 INC.
    Product Code
    QNR
    UDI-DI
    10850007732247
    PMA / PMN Number
    K230364
    Removal / Correction Number
    3011468686-10/10/2025-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VITALFLOW CONSOLE INSTRUMENT'S SCREEN WENT WHITE FOR 2 MINUTES WHILE AN ECMO NURSE WAS CHECKING THE ALARM HISTORY. THE PUMP CONTINUED TO RUN, AND THE RPMS WERE MAINTAINED ON THE SECONDARY INDICATOR LIGHT DURING THIS TIME. THE SCREEN RETURNED TO NORMAL AFTER 2 MINUTES, AND THE REST OF THE RUN WAS UNEVENTFUL. THE INSTRUMENT IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241350 VITALFLOW CONSOLE BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR MC3 INC. 58100 10850007732247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male