BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3033583 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08293
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 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 SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE US AND DOES NOT HAVE A 510K NUMBER. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE ROOT CAUSE OF THE DEFECTIVE BATTERY IS UNKNOWN. 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 PRODUCT EVALUATION BY A SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED BATTERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136268 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1