BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4243451 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39901
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 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 WAS PERFORMED AND EVIDENCE OF AN F-94 ALARM WAS IDENTIFIED. VISUAL INSPECTION IDENTIFIED A DAMAGED POWER CORD, WHICH WILL BE CAPTURED AND REPORTED IN (B)(4). POWER ON SELF-TESTING WAS PERFORMED AND VERIFIED THE REPORTED CONDITION; AN F-94 ALARM WAS ENCOUNTERED. THE CAUSE OF THE ALARM WAS DETERMINED TO BE AN ISSUE WITH THE MAIN BATTERIES. TO CORRECT THE CONDITION, THE MAIN BATTERIES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP PRESENTED AN F-94 ALARM. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726317 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1