BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 CONVECTIVE WARMER

    MDR report key: 23546854 · Received November 13, 2025

    Report

    Report Number
    3012307300-2025-12456
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 10, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DWJ
    UDI-DI
    50695085850005
    PMA / PMN Number
    K141686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3/H6: THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED. A FUNCTIONAL TEST WAS PERFORMED, AND THE REPORTED ISSUE WAS CONFIRMED. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO DEFECTIVE MAIN PCB. AS A RESULT, THE MAIN PCB BOARD ASSY B(7012103) WAS REPLACED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE DEVICE PASSED ALL FUNCTIONAL TESTING AFTER REPAIR

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE POWER SUPPLY CUT OFF MIDWAY AND FAILED TO TURN ON AFTERWARD. THIS OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS A PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883243 LEVEL 1 CONVECTIVE WARMER SYSTEM, THERMAL REGULATING DWJ ICU MEDICAL, INC. 50695085850005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown