BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2972629 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04350
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    October 30, 2012
    Report Date
    February 4, 2013
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF "NOT WORKING" WAS CONFIRMED BY THE BAXTER QUALITY ENGINEER AS A MAIN BATTERY ISSUE. THE ASSIGNABLE CAUSE WAS IDENTIFIED AS A DEFECTIVE MAIN BATTERY THE MAIN BATTERY WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A FLOGARD INFUSION PUMP WITH A BATTERY ISSUE. THE FACILITY REPRESENTATIVE INITIALLY REPORTED THE PUMP "WAS NOT WORKING." BAXTER QUALITY ENGINEERING DETERMINED THE REPORTED CONDITION TO BE A MAIN BATTERY ISSUE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO 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
    76030 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1