BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3211711 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17733
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 9, 2013
    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. A REVIEW OF THE ALARM LOG IDENTIFIED ALARM F38. THIS ALARM INDICATED THAT THE FORCE SENSING RESISTOR (FSR) WAS OUT OF CALIBRATION. THE FSR WAS REPLACED TO FIX THE REPORTED CONDITION. THE PUMP PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER IN WORKING ORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP PRESENTED AN F-38 ALARM. THE PROCESS STEP THAT THIS MALFUNCTION WAS IDENTIFIED IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309401 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1