BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3252361 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-20023
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 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). THE DEVICE WAS EVALUATED ON-SITE BY A FIELD SERVICE TECHNICIAN. DURING ON-SITE EVALUATION, VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE DAMAGED BATTERIES. THE BATTERIES WERE REPLACED TO CORRECT THE REPORTED CONDITION. THE DEVICE WAS RETURNED TO THE CUSTOMER IN GOOD WORKING CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP GENERATED A 94 ALARM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352912 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1