BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 18826731 · Received March 4, 2024

    Report

    Report Number
    18826731
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    December 2, 2023
    Report Date
    December 4, 2023
    Manufacturer
    SVS LLC
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SYSTEM CONTINUES TO LOSE PRESSURE QUICKLY. IMMEDIATELY AFFECTING LINE MAINTENANCE AND PRESSURE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060118 PREMIERPRO INFUSOR, PRESSURE, FOR I.V. BAGS KZD SVS LLC 8817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown