BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3944177 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23251
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 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 DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. A REVIEW OF THE ALARM LOG FOUND EVIDENCE OF AIR IN LINE ALARM. THE DEVICE WAS FUNCTIONALLY TESTED BY PERFORMING A POWER-ON SELF-TEST. THE POWER ON SELF-TEST VERIFIED THE REPORTED ISSUE. THE CAUSE WAS DETERMINED TO BE AIR SENSORS THAT WERE OUT OF CALIBRATION. THE AIR SENSORS WERE CALIBRATED TO RESOLVE THE CONDITION. 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

    A CUSTOMER REPORTED A FLOGARD PUMP WITH AN AIR IN LINE ALARM. IT IS UNKNOWN WHAT PROCESS STEP THIS ALARM OCCURRED DURING. THERE WAS NO PATIENT INVOLVEMENT, AND THEREFORE NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422743 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1