BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3142479 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-13959
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. THE FLOGARD PUMP WAS RETURNED FOR EVALUATION. THE PUMP WAS VISUALLY INSPECTED. DURING INSPECTION ALARM F_67 WAS EXPERIENCED WHEN THE PUMP WAS TURNED ON. THIS ALARM INDICATES A DEFECTIVE CENTRAL PROCESSING UNIT (CPU) BOARD. THE CPU BOARD WAS REPLACED TO FIX THE REPORTED CONDITION. THE PUMP PASSED ALL TESTS AND WAS RETURNED TO THE CUSTOMER IN WORKING ORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP DISPLAYED "ERROR F_67". IT IS UNKNOWN DURING WHAT PROCESS STEP THAT THIS ALARM WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244444 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1