BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3183066 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16191
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 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). (B)(6). THE DEVICE WAS EVALUATED AT THE CUSTOMER SITE BY A BAXTER SERVICE TECHNICIAN. A POWER ON SELF TEST REVEALED THE REPORTED F_94 ALARM. THE CAUSE OF THE ALARM WAS DETERMINED TO BE A DAMAGED MAIN BATTERY. IN ORDER TO ADDRESS THE REPORTED CONDITION THE MAIN BATTERY WAS REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. 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 EXPERIENCED AN F_94 ALARM. IT IS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282481 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1