BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3243905 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19522
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. A REVIEW OF THE ALARM LOG IDENTIFIED THAT THE F-94 ALARM OCCURRED. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. SERVICE DETERMINED THAT THE CAUSE OF THE F-94 ALARM WAS A DAMAGED MAIN BATTERY. IN ORDER TO CORRECT THE CONDITION, THE MAIN BATTERY WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP HAD EXPERIENCED AN F-94 ALARM. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344163 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1