BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE

    MDR report key: 22319826 · Received June 24, 2025

    Report

    Report Number
    1314417-2025-00041
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 16, 2025
    Report Date
    January 5, 2025
    Manufacturer
    AIRLIFE
    Product Code
    CAI
    UDI-DI
    10889483598924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED ALL INFORMATION REASONABLY KNOWN AS OF 24 JUN 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINAN/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    CORRECTION: G1. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; ADDITIONALLY, NO PHOTOGRAPHIC/VIDEOGRAPHIC EVIDENCE WAS PROVIDED BY THE REPORTER. INVESTIGATION OF THE FAILURE MODE: LOWER CONNECTING PART BROKE DURING USE, WAS PERFORMED USING RETAINED SAMPLES WHICH WERE INSPECTED FOR CRACKS OUT OF THE PACKAGE, NO CRACKS WERE FOUND. THE SAMPLES WERE ASSEMBLED AND PUT INTO HEAT TO ACCELERATE THE AGING PROCESS FOR ONE YEAR, WHEN INSPECTED, NO CRACKS WERE IDENTIFIED. A SEPARATE SAMPLE SET WAS ASSEMBLED AND PUT INTO HEAT TO ACCELERATE THE AGING PROCESS FOR TWO YEARS, WHEN INSPECTED, NO CRACKS WERE IDENTIFIED. A SEPARATE SAMPLE SET WAS ASSEMBLED, INSPECTED FOR CRACKS, AND CONNECTED TO CORRECT SIZED AND INCORRECT SIZED ENDOTRACHEAL TUBES. WHEN INSPECTED FOR CRACKS, NONE WERE IDENTIFIED. THE OVERALL OBSERVATION FROM THE STUDY PERFORMED WAS THAT NO CRACKS WERE NOTICED AND THE REPORTED FAILURE MODE: LOWER CONNECTING PART BROKE DURING USE, COULD NOT BE REPLICATED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 05 JAN 2026 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (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 AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE VERSO ADAPTER BROKE DURING USE, THE PATIENT SHOWED A HIGH LEAK ON THE VENTILATOR; THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE VERSO ADAPTER BROKE DURING USE, THE PATIENT SHOWED A HIGH LEAK ON THE VENTILATOR; THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390052 AIRLIFE AIRLIFE NEO-VERSO¿ "Y" AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES CAI AIRLIFE CSC300 UNKNOWN 10889483598924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown