BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3840513 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17371
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    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 INFUSION PUMP WAS SERVICED ON-SITE. VISUAL INSPECTION, POWER ON SELF-TEST, BATTERY TEST AND AN ALARM LOG REVIEW WERE PERFORMED. DURING THE POWER ON SELF TEST AND BATTERY TEST THE BATTERY LOW ALARM WAS IDENTIFIED. THE CAUSE OF THE ALARM WAS A LOW BATTERY. THE BATTERY WAS REPLACED TO CORRECT THE CONDITION. THE PUMP PASSED ALL TESTING AND WAS RETURNED TO GOOD WORKING ORDER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING ON-SITE SERVICE, A BAXTER SERVICE TECHNICIAN EXPERIENCED A BATTERY LOW ALARM ON A FLOGARD INFUSION PUMP. THIS MALFUNCTION WAS IDENTIFIED DURING SERVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319267 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1