BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4182750 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36391
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 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 BY A FIELD SERVICE TECHNICIAN AS PART OF PREVENTATIVE MAINTENANCE. THIS IS AN ANCILLARY SERVICE EVENT. A VISUAL INSPECTION AND A POWER ON SELF-TEST WERE PERFORMED. DURING THE POWER ON SELF-TEST A LOW BATTERY ALARM OCCURRED. THE ALARM WAS CAUSED BY A DEPLETED MAIN BATTERY. THE BATTERY WAS REPLACED; THE PUMP 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660379 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1