BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSORB PLUS

    MDR report key: 24187126 · Received January 27, 2026

    Report

    Report Number
    3002226076-2026-01518
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    October 17, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ARMSTRONG MEDICAL LTD
    Product Code
    CBL
    PMA / PMN Number
    9039632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ARMSTRONG MEDICAL LTD CONSIDER THIS CASE TO BE CLOSED.

    Description of Event or Problem · 0

    ARMSTRONG MEDICAL LTD RECEIVED A REPORT FROM MEDICAL INNOVATIONS TRADING REPORTING A QUALITY ISSUES WITH 3 HOSPITALS FOR A QUANTITY OF (B)(4) PCS OF AMAB3000 (AMSORB PLUS JERICAN 5 LITRE). ISSUES REPORTED WERE WITH: 1) POWDER DETECTION AND ALARM TRIGGERING 2) EARLY COLOR CHANGE AND INCREASED CONSUMPTION. ARMSTRONG MEDICAL LTD REQUESTED RETURN OF THE DEVICES, BUT THEY WERE NOT AVAILABLE TO RETURN. ARMSTRONG MEDICAL LTD HAVE NO EVIDENCE THAT THERE IS ANY PROBLEM WITH THE AMSORB, THE LOT WAS OUTPUT COMPLIANTLY. RETAIN WAS CHECKED AND WAS WITHIN RELEASE SPECIFICATIONS. ARMSTRONG MEDICAL LTD WERE THEREFORE UNABLE TO INVESTIGATE A ROOT CAUSE RESULTING IN NO CORRECTIVE OR PREVENTIVE ACTION BEING DETERMINED OR IMPLEMENTED. ARMSTRONG MEDICAL WILL CONTINUE TO MONITOR THESE DEVICES AS PART OF OUR POST-MARKET SURVEILLANCE AND VIGILANCE ACTIVITIES. NOTE THAT THIS EVENT OCCURRED IN UNITED ARAB EMIRATES, AS THE DEVICE IS AVAILABLE ON THE MARKET IN US, WE ARE OBLIGED TO NOTIFY THE FDA AS PER MDSAP REQUIREMENTS. AS THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249934 AMSORB PLUS CARBON DIOXIDE ABSORBENT CBL ARMSTRONG MEDICAL LTD AMAB3000 140624F51

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown