BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3902489 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20840
    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). (B)(6). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THE DEVICE WAS VISUALLY INSPECTED, FUNCTIONALLY TESTED AND THE ALARM LOG WAS REVIEWED. DURING POWER ON SELF-TEST AND ALARM LOG REVIEW THE AIR IN LINE ALARM WAS FOUND; THE CAUSE OF THIS WAS A DAMAGED CENTRAL PROCESSING UNIT (CPU) BOARD. TO CORRECT THE CONDITION, THE CPU PRINTED CIRCUIT BOARD (PCB) ASSEMBLY WAS REPLACED AND THE AIR SENSOR WAS RECALIBRATED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE AN AIR ALARM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381199 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1