BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3950906 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23691
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    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). (B)(6). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. A REVIEW OF THE ALARM LOG FOUND EVIDENCE OF THE F94 ALARM. VISUAL INSPECTION FOUND THE DEVICE IN A GOOD PHYSICAL CONDITION. THE DEVICE WAS FUNCTIONALLY TESTED BY PERFORMING A POWER-ON SELF-TEST. THE POWER ON SELF-TEST VERIFIED THE REPORTED ISSUE. THE CAUSE WAS DETERMINED TO BE A DAMAGED MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO RESOLVE THE CONDITION. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING AN F94 ALARM ON THE FLOGARD INFUSION PUMP. IT IS UNKNOWN WHAT PROCESS STEP THIS ALARM OCCURRED DURING. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428682 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1