BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3873596 · Received June 15, 2014

    Report

    Report Number
    1416980-2014-19086
    Event Type
    Malfunction
    Date Received
    June 15, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 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). THE DEVICE WAS SERVICED ON-SITE BY A BAXTER SERVICE TECHNICIAN. A VISUAL INSPECTION, POWER ON SELF-TEST AND BATTERY TESTING WERE PERFORMED. DURING BATTERY TESTING A BATTERY LOW ALARM WAS FOUND. THE CAUSE OF THE ALARM WAS A DEPLETED MAIN BATTERY. THE MAIN BATTERY WAS REPLACED. THE DEVICE PASSED ALL SPECIFICATIONS AND WAS RETURNED TO GOOD WORKING CONDITION. 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 FOUND THAT THE FLO-GARD EXPERIENCED A BATTERY LOW ALARM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351904 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1