BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOLIME

    MDR report key: 23560517 · Received November 14, 2025

    Report

    Report Number
    1924066-2025-00083
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 14, 2025
    Manufacturer
    ALLIED MEDICAL LLC.
    Product Code
    CBL
    UDI-DI
    00026072025321
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A PROCEDURE, THE CO2 ABSORBENT CANISTER FAILED AND REQUIRED INTERVENTION. NO PATIENT HARM OCCURRED. THE DEVICE HAS NOT BEEN RETURNED FOR PROPER INVESTIGATION.

    Description of Event or Problem · 0

    CUSTOMER HAS REPORTED LEAK TEST, FAILURES, ISSUES REQUIRING INTERVENTION MID CASE AT LEAST ONCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790118 CARBOLIME CARBOLIME, GE MULTI-STYLE CARTRIDGE CBL ALLIED MEDICAL LLC. 55-01-0027 UNKNOWN 00026072025321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention