BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2973776 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04427
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). DEVICE EVALUATION: THE REPORTED PROBLEM OF "NOT WORKING" WAS CONFIRMED DURING EVALUATION AS FAILURE CODE 94. THE ASSIGNABLE CAUSE WAS IDENTIFIED AS A DEFECTIVE MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT IS "NOT WORKING". UPON FURTHER INVESTIGATION, THE QUALITY ENGINEER CONFIRMED THE REPORTED CONDITION AS FAILURE CODE 94. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78154 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1