BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE LOW FLOW SYSTEMS

    MDR report key: 18562168 · Received January 23, 2024

    Report

    Report Number
    2183161-2024-00093
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    December 25, 2023
    Report Date
    March 4, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    UDI-DI
    50695085820909
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. HL-90JP 510K: THIS IS AN INTERNATIONAL CODE - THE MODEL#/CATALOG# IDENTIFIED IN SECTION D4 IS A SMITHS MEDICAL PRODUCT WHICH IS THE SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS HL-90. THE 510K NUMBER PROVIDED IN SECTION G5 IS FOR THE DOMESTIC SIMILAR PRODUCT: K911383. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED IN ACCORDANCE WITH 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    H6 - UPDATED ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED COMPLAINT WAS CONFIRMED. THERE WERE CRACKS AT THE BOTTOM OF THE TANK CAUSING THE DEVICE TO LEAK. REPAIR IS NOT POSSIBLE AS IT HAS BEEN OVER 20 YEARS SINCE MANUFACTURE. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A WATER LEAK FROM THE TANK. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799470 LEVEL 1 HOTLINE LOW FLOW SYSTEMS WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC. HL-90 50695085820909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown