BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE

    MDR report key: 22549423 · Received July 18, 2025

    Report

    Report Number
    1314417-2025-00050
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 18, 2025
    Manufacturer
    AIRLIFE
    Product Code
    CAT
    UDI-DI
    10190752116252
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 18 JULY 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 THE COMPLAINT REPORTED, "THE CONNECTION BETWEEN THE TUBING AND OUR EQUIPMENT DISCONNECTS WITH THE SLIGHTEST MOVEMENT DUE TO THE STIFFNESS OF THE CONNECTION MATERIAL." THE ISSUE OCCURRED DURING PATIENT USE; HOWEVER, NO PATIENT WAS AFFECTED OR HARMED. SINCE NO SAMPLE, PHOTOS, OR VIDEO WERE PROVIDED, THE COMPLAINT COULD NOT BE CONFIRMED; THEREFORE, NO ROOT CAUSE WAS DETERMINED. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE REPORTING TO THE CAPA REVIEW BOARD THIS IS THE THIRD COMPLAINT REPORTED FOR PART NUMBER 001350, " DISCONNECTION/CONNECTION ISSUE(S) " FAILURE MODE. THERE WAS ONE OTHER COMPLAINT REPORTED FOR PART NUMBER 001350 DURING THE SAME TIMEFRAME. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    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 18 JULY 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 21 CFR 803, 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: LOOSE CONNECTION BETWEEN THE TUBING AND THE EQUIPMENT; IT LITERALLY FALLS OFF WITH THE SLIGHTEST BIT OF MOTION THE MATERIAL FEELS STIFF. NO REPORTED INJURY. WHILE NO HARM OR INJURY WAS REPORTED, ANY COMPONENT THAT IS PART OF THE VENT CIRCUIT (FLEX CONNECTOR, DOUBLE SWIVEL ELBOW, Y-ADAPTER, T-PIECE, ETT ADAPTER, ETC.) BREAKS, CRACKS, OR LEAKS AFTER THE VENT CIRCUIT HAS BEEN ESTABLISHED ON THE PATIENT COULD CAUSE A DELAY IN CARE AND OR LEAD TO A SERIOUS INJURY

    Description of Event or Problem · 0

    IT WAS REPORTED: LOOSE CONNECTION BETWEEN THE TUBING AND THE EQUIPMENT; IT LITERALLY FALLS OFF WITH THE SLIGHTEST BIT OF MOTION THE MATERIAL FEELS STIFF. NO REPORTED INJURY. WHILE NO HARM OR INJURY WAS REPORTED, ANY COMPONENT THAT IS PART OF THE VENT CIRCUIT (FLEX CONNECTOR, DOUBLE SWIVEL ELBOW, Y-ADAPTER, T-PIECE, ETT ADAPTER, ETC.) BREAKS, CRACKS, OR LEAKS AFTER THE VENT CIRCUIT HAS BEEN ESTABLISHED ON THE PATIENT COULD CAUSE A DELAY IN CARE AND OR LEAD TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712865 AIRLIFE AIRLIFE¿ U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1 M) CRUSH-RESISTANT OXYGEN TUBING CAT AIRLIFE 001350 UNKNOWN 10190752116252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other