BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3781711 · Received April 30, 2014

    Report

    Report Number
    1416980-2014-14012
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 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). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. THE CAUSE OF THE F-74 ALARM WAS DETERMINED TO BE AN INOPERATIVE CENTRAL PROCESSING UNIT (CPU) BOARD. TO CORRECT THE CONDITION, THE DEVICE WAS REMOVED FROM SERVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING PRODUCT SERVICE BY A SERVICE TECHNICIAN, A FLOGARD INFUSION PUMP WAS FOUND TO HAVE PRESENTED AN F-74 ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259614 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1