BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2936031 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02340
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION WAS CONFIRMED DURING DEVICE EVALUATION. THE ROOT CAUSE WAS DUE TO THE FORCE SENSING RESISTORS BEING OUT OF RANGE. THE FORCE SENSING RESISTORS WERE REPLACED TO CORRECT THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A FLOGARD INFUSION PUMP HAD AN F-38 ALARM. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40694 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1