BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 6222859 · Received January 4, 2017

    Report

    Report Number
    1416980-2016-19018
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Date of Event
    December 10, 2016
    Report Date
    January 4, 2017
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. VISUAL INSPECTION, FUNCTIONAL TESTING, AND A REVIEW OF THE ALARM LOG WERE PERFORMED. THE F-23 ALARM WAS IDENTIFIED DURING FUNCTIONAL TESTING AND THE REVIEW OF THE ALARM LOG. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A DAMAGED CPU BOARD. THE DEVICE WAS REMOVED FROM SERVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING PRODUCT SERVICE BY A SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE F23 ALARM (P50 (IRQ INTERRUPT PORT) REMAINS HIGH). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4712 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1