BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4142425 · Received October 5, 2014

    Report

    Report Number
    1416980-2014-34547
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 10, 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 BATTERY TESTING THE BATTERY WAS FOUND TO BE DAMAGED; THE CAUSE OF THIS WAS UNKNOWN. TO CORRECT THE CONDITION, THE BATTERY WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP HAD A DAMAGED BATTERY. 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
    621953 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1