BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA SP TIVA RO

    MDR report key: 19188876 · Received April 26, 2024

    Report

    Report Number
    3000240707-2024-00115
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 25, 2024
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: AT THE BEGINNING OF INFUSION PROCEDURE, ON THE DEVICE SCREEN THE FOLLOWING ERROR MESSAGE WAS DISPLAYED: "98-0004 UNEXPECTED RESET". ERROR 98 IS IDENTIFIED IN THE TECHNICAL MANUAL AS A DEFECTIVE RESET CIRCUIT. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982869 AGILIA SP TIVA RO INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown