BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER, THERMAL, INFUSION FLUID PRODUCT CODE: LGZ

    MDR report key: 8534287 · Received April 20, 2019

    Report

    Report Number
    3012307300-2019-02134
    Event Type
    Malfunction
    Date Received
    April 20, 2019
    Report Date
    September 25, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    UDI-DI
    50695085812904
    PMA / PMN Number
    K072080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: THE FILE WAS INADVERTENTLY MARKED REPORTABLE. THE EVENT REPORTED UNDER MFR 3012307300-2019-02134 WAS DETERMINED TO BE NOT REPORTABLE AND NO FURTHER REPORTS WILL BE FILED USING THIS FILE NUMBER. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL NORMOFLO FLUID WARMING DEVICE, IRRIGATING SYSTEM WAS LEAKING WATER, CUSTOMER SUSPECTS BAD COMPRESSOR. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327142 WARMER, THERMAL, INFUSION FLUID PRODUCT CODE: LGZ WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC. 50695085812904

    Patients

    Seq Age Sex Outcome Treatment
    1