BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUINOX WARMER BLACK OVERLAY MEMBRANE SWITCH

    MDR report key: 22731879 · Received August 6, 2025

    Report

    Report Number
    3012307300-2025-09410
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    June 11, 2025
    Report Date
    October 31, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    NII
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO PRODUCT RETURNED FOR DEVICE ANALYSIS; A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    E: PHONE NUMBER EXT. - (B)(6). 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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAINTENANCE PARTS RECEIVED UNDER INVOICE NF6808 FOR THE LEVEL 1 EQUIPMENT INCLUDED TWO UNITS OF THE PANEL MEMBRANE WITH CONTROL BUTTONS PACKAGED TOGETHER WITHIN A SINGLE MANUFACTURER-LABELED BAG. HOWEVER, THE INVOICE INDICATED THAT TWO UNITS WERE EXPECTED, WHICH IMPLIES THEY SHOULD HAVE BEEN DELIVERED IN SEPARATE PACKAGES. THE IMMEDIATE ACTIONS TAKEN WERE THAT ONE OF THE TWO UNITS WAS REMOVED FROM THE ORIGINAL PACKAGING AND PLACED INTO A NEW PLASTIC BAG, WITH PROTECTIVE BUBBLE WRAP SURROUNDING THE PRODUCT. THE STATUS OF THE PRODUCT WAS UPON REMOVAL FROM PACKAGE. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505566 EQUINOX WARMER BLACK OVERLAY MEMBRANE SWITCH NI NII ICU MEDICAL, INC. P0787252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown