BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS, ADAPTER, AC, WALLWART, AMBULATORY ACCESSORIES

    MDR report key: 22311674 · Received June 23, 2025

    Report

    Report Number
    3012307300-2025-07534
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    December 5, 2024
    Report Date
    June 23, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    15019517126884
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE CUSTOMER REPORTED ISSUE OF ¿THE BATTERY COMPARTMENT WAS DAMAGED¿ COULD NOT BE CONFIRMED, NO SIGNS OR SMELLS OF BURNING COULD BE OBSERVED. THE ALTERNATING CURRENT (AC) ADAPTER DID NOT WORK WHEN CONNECTED TO MAINS. A HISTORY REVIEW IS NOT APPLICABLE AS THE PRODUCT IS A SUPPLIED ITEM. NO ACTION TAKEN, THE ITEM IS A PURCHASED FINISHED GOOD (PFG) AND WILL BE SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A STRONG BURN SMELL WAS COMING FROM DEVICE. THE FAULTY POWER SUPPLY WAS REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970899 CADD-SOLIS, ADAPTER, AC, WALLWART, AMBULATORY ACCESSORIES PUMP, INFUSION FRN ICU MEDICAL, INC. 2107 15019517126884

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown