BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3903461 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20979
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 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). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN AS PART OF PREVENTATIVE MAINTENANCE. THIS IS AN ANCILLARY SERVICE EVENT. VISUAL INSPECTION, FUNCTIONAL TESTING, AND BATTERY TESTING WERE PERFORMED. THE F-73 ALARM OCCURRED DURING FUNCTIONAL TESTING OF THE DEVICE. THE CAUSE OF THE F-73 ALARM WAS DETERMINED TO BE LOOSE MOTOR COUPLINGS. TO CORRECT THE CONDITION, THE SCREWS WERE SET AND TIGHTENED. 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

    DURING PRODUCT SERVICE BY A FIELD SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP PRESENTED THE F-73 ALARM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379372 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1