BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3070308 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-09952
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    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 PREVENTATIVE MAINTENANCE. THE ROOT CAUSE OF DAMAGE TO THE DOOR SHIM IS UNKNOWN. TO CORRECT THE CONDITION, THE DOOR SHIM WAS REPLACED. IF ANY ADDITIONAL RELEVANT 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 DOOR SHIM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172131 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1