BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISORB

    MDR report key: 22692402 · Received August 1, 2025

    Report

    Report Number
    3010838917-2025-00008
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 1, 2025
    Manufacturer
    AIRLIFE FINLAND OY
    Product Code
    CBL
    UDI-DI
    10889483577417
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01 AUG 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT - (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. ANAESTHETIC MACHINE FAULT - CIRCUIT WILL NOT PRESSURIZE. UNABLE TO RESOLVE THEREFORE ENGINEER CONTACTED WHO INVESTIGATED FAULT. RESULT: FAULTY MEDISORB CANNISTER - NO VISIBLE SIGNS OF ANY DAMAGE. ONCE CANNISTER RENEWED MACHINE IN WORKING ORDER. NUMBER OF PATIENTS INVOLVED: 0 . THE COMPLAINT OF "ANAESTHETIC MACHINE FAULT - CIRCUIT WILL NOT PRESSURIZE. " REGARDING PART 2079796-001 WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 0 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01 AUG 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT: (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ANESTHETIC MACHINE FAULT. THE CIRCUIT WOULD NOT PRESSURIZE. IT IS UNKNOWN IF THERE WAS PATIENT INJURY, HARM OR DELAY IN THERAPY, ALTHOUGH, IF THIS MALFUNCTION WERE TO RECUR DURING PATIENT USE THERE IS A POSSIBILITY OF DELAY IN TREATMENT, SERIOUS INJURY OR HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ANESTHETIC MACHINE FAULT. THE CIRCUIT WOULD NOT PRESSURIZE. IT IS UNKNOWN IF THERE WAS PATIENT INJURY, HARM OR DELAY IN THERAPY, ALTHOUGH, IF THIS MALFUNCTION WERE TO RECUR DURING PATIENT USE THERE IS A POSSIBILITY OF DELAY IN TREATMENT, SERIOUS INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025908 MEDISORB MEDISORB¿ EX, DISPOSABLE CBL AIRLIFE FINLAND OY 2079796-001 L01A-02213 10889483577417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other