BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 8937534 · Received August 27, 2019

    Report

    Report Number
    3012307300-2019-04427
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Report Date
    August 27, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ONE LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-90) WAS RECEIVED IN FAIR CONDITION. THE DISPOSABLE ALARM THAT THE CUSTOMER COMPLAINED OF WAS CAUSED BY A DAMAGED MICRO SWITCH. BECAUSE OF THE DAMAGED PART, THE DEVICE WAS UNABLE TO CONSISTENTLY FUNCTION AS INTENDED. AFTER A NEW MICRO SWITCH (PN 7004012) WAS INSTALLED THE DUT FUNCTIONED FINE. THE OVER TEMP ISSUE COULD NOT BE CONFIRMED. AFTER REPAIR, THE DEVICE WAS OPERATED FOR SEVERAL HOURS WITHOUT ISSUES. DISPOSABLE ALARM ISSUE WAS CONFIRMED. IT IS LIKELY THAT THE REPORTED DAMAGED WAS CAUSED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS INTERMITTENTLY RISING ABOVE THE SET TEMPERATURE (OVER TEMP) AND GIVING A DISPOSABLE ALARM. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731433 LEVEL 1 WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC

    Patients

    Seq Age Sex Outcome Treatment
    1