BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2935484 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02285
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED PROBLEM OF A FLOGARD INFUSION PUMP WITH AN "ALARM F94" WAS CONFIRMED IN THE SAMPLE EVALUATION. THE CAUSE OF THE PROBLEM WAS A DEFECTIVE MAIN BATTERY. THE MAIN BATTERY WAS REPLACED ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN TO FIX THE PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. THIS DEVICE WAS EVALUATED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE CUSTOMER REPORTED A FLOGARD PUMP WITH AN F94 ALARM. IT IS UNKNOWN IF THIS EVENT OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41397 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1