BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE FLUID WARMING SET WITH GAS VENT

    MDR report key: 1588844 · Received January 20, 2010

    Report

    Report Number
    2183502-2009-00507
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    December 13, 2009
    Report Date
    January 17, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    LGZ
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE TUBING BROKE OFF AT THE LUER DURING A PROCEDURE. THE PROCEDURE WAS DELAYED WHILE A NEW TUBING WAS OBTAINED. THERE WAS NO REPORTED INCIDENT RELATED MEDICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 HOTLINE FLUID WARMING SET WITH GAS VENT LGZ - WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention