BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSORB PLUS

    MDR report key: 23495185 · Received November 7, 2025

    Report

    Report Number
    3002226076-2025-00000
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    June 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

    NO CAPA MEASURES IMPLEMENTED AS IT WAS DEEMED THAT THE DEVICE DID NOT HAVE A FAULT.

    Description of Event or Problem · 0

    ARMSTRONG MEDICAL LTD RECEIVED (B)(4) FROM GE HEALTHCARE ((B)(6)) HAVE REPORTED AN ISSUE WITH AMAB3801GE LOT 300924F11. OUT OF THE EIGHT THAT WERE TESTED, FOUR FAILED. THIS WAS HIGHLIGHTED AFTER A LARGE LEAK WAS NOTICED WHILE A PATIENT WAS ATTACHED TO THE MACHINE. THE CO2 ABSORBER HAD TO BE REPLACED. REPORTS OF PATIENT INVOLVEMENT. 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 AND WE ARE SUBMITTING INITIAL AND FOLLOW UP REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861714 AMSORB PLUS CARBON DIOXIDE ABSORBENT CBL ARMSTRONG MEDICAL LTD 300924F11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMSORB PLUS.