BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3200430 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16968
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FLOGARD WAS SERVICED ON-SITE. DURING A REVIEW OF THE ALARM LOG A F94 ALARM WAS IDENTIFIED. THE MAIN BATTERY WAS REPLACED IN ORDER TO FIX THE REPORTED CONDITION. THE DEVICE UNDERWENT VISUAL INSPECTION AND PASSED ALL FUNCTIONAL TESTS. THE DEVICE WAS RETURNED TO THE CUSTOMER IN WORKING ORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP HAD EXPERIENCED AN F94 ALARM. THE PROCESS STEP THAT THIS MALFUNCTION WAS IDENTIFIED IS UNKNOWN. HOWEVER, THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299123 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1