BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2990222 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05289
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 14, 2013
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    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 FAILURE CODE 38 WAS CONFIRMED DURING DEVICE EVALUATION. THE ASSIGNABLE CAUSE WAS IDENTIFIED AS WITH THE FORCE SENSING RESISTORS (FSRS). THE FSRS WERE REPLACED TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON-SITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLOGARD PUMP REPORTED THAT THE EQUIPMENT PRESENTED THE ALARM F-38. NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION WERE REPORTED WHEN THIS EVENT WAS RECEIVED. ADDITIONAL INFORMATION IS NOT EXPECTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93762 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1