BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3841588 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17500
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    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). (B)(6). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED PROBLEM OF AN F-94 ALARM CODE WAS CONFIRMED IN THE SAMPLE EVALUATION AND EVENT HISTORY LOG REVIEW. THE CAUSE OF THE REPORTED PROBLEM WAS IDENTIFIED AS DEFECTIVE MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED IN ORDER TO RESOLVE THIS CONDITION. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING AN F-94 ALARM CODE ON THE FLOGARD INFUSION PUMP. IT IS UNKNOWN WHAT PROCESS STEP THIS ALARM OCCURRED DURING. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318425 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1