BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSORB PLUS

    MDR report key: 23496814 · Received November 7, 2025

    Report

    Report Number
    3002226076-2025-00923
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    May 12, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ARMSTRONG MEDICAL LTD
    Product Code
    CBL
    PMA / PMN Number
    9616692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ACCOUNT MANAGER REQUESTED IF THE FAULTY PRODUCT WAS AVAILABLE FOR RETURN AND ACTION IF AVAILABILITY CONFIRMED. NO RETURNS WERE EVER PROVIDED FOR UPLIFT AND RETURN. NO FURTHER INVESTIGATION WAS POSSIBLE. RETURN EVENTUALLY WERE RECEIPTED AND CONFIRMED BROKEN AND WOULD NOT HAVE PASSED TEST. PRODUCT WOULD NOT HAVE PASSED 100% TESTING ON SITE- SUSPECTED TRANSPORT DAMAGE.

    Description of Event or Problem · 0

    ARMSTRONG MEDICAL LTD RECEIVED A COMPLAINT FROM (GE HEALTHCARE) (B)(6) HOSPITAL (B)(6) REPORTED THAT DURING A PROCEDURE WHILE THE PATIENT WAS INTUBATED THE GE AISYS ANESTHESIA MACHINE BEGAN LEAKING. THE DISPOSABLE CO2 CANISTER WAS FOUND TO BE CRACKED, WHICH CAUSED THE LEAK. PRODUCT CODE: AMAB3801GE--- LOT NUMBER 090924F11. ARMSTRONG MEDICAL LTD CONSIDER THIS TO BE A REPORTABLE EVENT AS IT MEETS ALL THREE BASIC REPORTING CRITERIA A-C OF MEDDEV 2 12-1 REV.8 AND MDR ARTICLE 2 (65). THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM REPORTED. AS THIS PRODUCT IS AVAILABLE ON THE MARKET IN THE US, WE ARE OBLIGED TO REPORT TO FDA. PLEASE NOTE THAT DUE TO IT ISSUES WITH THE US PORTAL, ARMSTRONG MEDICAL LTD HAVE BEEN UNABLE TO SUBMIT REPORTS TO THE FDA UNTIL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177581 AMSORB PLUS CARBON DIOXIDE ABSORBENT CBL ARMSTRONG MEDICAL LTD 090924F11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMSORB PLUS