BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4141500 · Received October 4, 2014

    Report

    Report Number
    1416980-2014-34501
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 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). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. VISUAL INSPECTION, POWER ON SELF-TEST, BATTERY TESTING AND A REVIEW OF THE ALARM LOG WERE PERFORMED. DURING POWER ON SELF-TEST AND ALARM LOG REVIEW THE F-38 ALARM WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DAMAGED FORCE SENSING RESISTORS (FSR). TO CORRECT THE CONDITION, THE FSRS WERE REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED AN F-38 ALARM. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621161 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1