BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3143069 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14114
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. THE ROOT CAUSE OF THE BATTERY LOW ALARM WAS DETERMINED TO BE A DEFECTIVE BATTERY. TO CORRECT THE CONDITION, THE BATTERY WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING THE PRODUCT EVALUATION BY A SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE A LOW BATTERY ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245047 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1