BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9617604-2008-00075

    MDR report key: 1253033 · Received September 12, 2008

    Report

    Report Number
    9617604-2008-00075
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Product Code
    LGZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A THOROUGH INVESTIGATION INTO THIS REPORT CANNOT BE CONDUCTED. THE USER FACILITY HAS NOT PROVIDED US WITH ANY ADDITIONAL INFO. A REVIEW OF MFG RECORDS COULD NOT BE PERFORMED AS THE USER FACILITY HAS NOT PROVIDED THE LOT NUMBER USED. A REVIEW OF THE INSTRUCTIONS FOR USE SUPPLIED WITH THE WARMING SET AND THE OPERATOR'S MANUAL SUPPLIED WITH THE FLUID WARMER REVEALS A WARNING THAT STATES "ALL AIR MUST BE REMOVED FROM THE INTRAVENOUS FLUID LINES BEFORE CONNECTING TO THE PT. FAILURE TO DO SO MAY RESULT IN INTRODUCTION OF AIR TO THE PT. MONITOR INTRAVENOUS FLUID LINE TO MAKE SURE IT IS AIR-FREE." THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LGZ

    Patients

    Seq Age Sex Outcome Treatment
    1