BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER, THERMAL, INFUSION FLUID PRODUCT CODE: LGZ

    MDR report key: 8698572 · Received June 14, 2019

    Report

    Report Number
    3012307300-2019-03617
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    March 1, 2019
    Report Date
    June 13, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ITEM NUMBER OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL "LEVEL 1-TOWER, KEEPS ALARMING WITH DISPOSABLE SET". NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493259 WARMER, THERMAL, INFUSION FLUID PRODUCT CODE: LGZ LGZ SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1