BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2981321 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04823
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 15, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF "DID NOT FUNCTION" WAS CONFIRMED DURING DEVICE EVALUATION AS FAILURE CODE 94. THE ASSIGNABLE CAUSE WAS A DAMAGED 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 "DID NOT FUNCTION". UPON FURTHER INVESTIGATION, THE QUALITY ENGINEER CONFIRMED THE REPORTED CONDITION AS A 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
    84318 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1