BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR LIFE

    MDR report key: 23549637 · Received November 13, 2025

    Report

    Report Number
    3004748541-2025-00120
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    September 23, 2025
    Report Date
    February 6, 2026
    Manufacturer
    SALTER LABS DE MEXICO DE S.A. DE C.V.
    Product Code
    BYX
    UDI-DI
    10889483570111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5. ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: D4; H2; H6. ANALYSIS OF THE VIDEO PROVIDED BY THE REPORTER, THE TUBING APPEARED TO CONFIRM THE REPORTED EVENT OF TUBE//DISCONNECTION WHEN PULLED (WHEN THE RESUSCITATION BAG WAS MOVED AROUND). FUNCTIONAL TESTING WAS PERFORMED USING THE MANUFACTURER PROVIDED 001350 TUBING, FROM A DIFFERENT LOT/BATCH ON A RESUSCITATION BAG PROVIDED BY THE REPORTER (NOT THE SUBJECT OF THE REPORTED EVENT). THE TEST RESULTS SHOWED THE TUBING PORT ON THE RESUSCITATION BAG WAS NOT ISO STANDARD; HOWEVER, THE TUBING WAS ABLE TO BE SEATED PROPERLY AND REMAINED ATTACHED DURING SIMULATED USE, INCLUDING WHEN THE TUBING WAS BEING PULLED. THE REPORTED ISSUE WAS NOT CONFIRMED DURING TESTING. THE MOST LIKELY ROOT CAUSE IS USER ERROR; IF THE TUBING IS ONLY SEATED ON THE TAPERED SECTION OF THE RESUSCITATION BAG PORT, IT WILL FALL OFF. THE DEVICE HISTORY RECORD FOR LOT 001350 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 06 FEB 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 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

    THE PRODUCT INVOLVED IN THE REPORT IS NOT AVAILABLE FOR RETURN. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 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: DURING MORNING (AM) ASSESSMENTS, THE OXYGEN TUBING WAS FOUND DISCONNECTED FROM THE BAG; THERE WAS NO REPORT OF A DELAY IN THERAPY AND/OR HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2025-00121 FOR THE SECOND REPORT. IT WAS REPORTED: DURING MORNING (AM) ASSESSMENTS, THE OXYGEN TUBING WAS FOUND DISCONNECTED FROM THE BAG; THERE WAS NO REPORT OF A DELAY IN THERAPY AND/OR HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25294 AIR LIFE TUBING OXYGEN SUPPLY 7FT CRUSH-RESISTANT U-CONNECT BYX SALTER LABS DE MEXICO DE S.A. DE C.V. 001350 544764 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown