BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21-2112-0400-51

    MDR report key: 24345480 · Received February 16, 2026

    Report

    Report Number
    3012307300-2026-01298
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    January 1, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    MEA
    UDI-DI
    10610586041051
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RECEIVED FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED ANALYSIS. THE CUSTOMER REPORTED COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. THE PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCEA BUTTON ON THE UNIT IS BROKEN AND DOESN'T RESPOND WHEN PRESSED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406757 21-2112-0400-51 PUMP, INFUSION, PCA MEA ICU MEDICAL, INC. 2110 10610586041051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown