BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3050925 · Received April 10, 2013

    Report

    Report Number
    1416980-2013-08954
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    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 IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE ROOT CAUSE OF THE LOW 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. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US BUT IS SAME OR SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES. THE 510K NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148776 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1