BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE LOW FLOW SYSTEMS

    MDR report key: 18562350 · Received January 23, 2024

    Report

    Report Number
    2183161-2024-00096
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    December 25, 2023
    Report Date
    February 21, 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

    H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR INVESTIGATION. NO ABNORMALITY WAS FOUND IN THE APPEARANCE. THE REPORTED PROBLEM WAS NOT DUPLICATED OR CONFIRMED. THIS PRODUCT DOES NOT INCLUDE A FLOW SENSOR. THE ROOT CAUSE IS UNKNOWN BECAUSE THE DEFECT EVENT CANNOT BE CONFIRMED. IT WAS CONFIRMED THAT THE FLOAT SENSOR, NOT THE FLOW SENSOR, ALSO FUNCTIONS PROPERLY. THE DEVICE PASSED THE FUNCTIONAL TEST AND PERFORMANCE TESTS. 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. NO ACTION IS TAKEN BECAUSE THE EVENT DOES NOT OCCUR AGAIN.

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. INITIAL REPORTER PHONE#: (B)(6). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLOW SENSOR WAS DEFECTIVE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533976 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