BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER O2 CANNULA

    MDR report key: 24463379 · Received February 26, 2026

    Report

    Report Number
    3004748541-2026-00044
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 26, 2026
    Manufacturer
    SALTER LABS
    Product Code
    BYX
    UDI-DI
    10889483570111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    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 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 26 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 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 AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, DURING REPOSITIONING OF THE PATIENT ON THE HOME CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE, THE OXYGEN TUBING BECAME DISCONNECTED FROM THE MACHINE AND THE PATIENT RAPIDLY DESATURATED. THE OXYGEN (O2) TUBING WAS RECONNECTED AND O2 INCREASED FROM 5L TO 15L; HOWEVER, THE PATIENT CONTINUED TO DESATURATE, WITH THE LOWEST SPO2 NOTED AT 67%. IT WAS ADDITIONALLY REPORTED, THE PATIENT WAS PLACED IN AN UPRIGHT POSITION IN BED AND THE MEDICAL PROFESSIONAL INITIATED BAG VALVE MASK (BVM) VENTILATION AT 100% FRACTION OF INSPIRED OXYGEN (FIO2) THE RESPIRATORY THERAPIST (RT) WAS CONTACTED, BY THE TIME RT ARRIVED, THE PATIENT'S SATURATIONS HAD COVERED TO 95%. THE CPAP WAS REAPPLIED BY RT AND THE PATIENT WAS REPOSITIONED AGAIN; THE OXYGEN TUBING, WHICH WAS CONNECTED TO CPAP, WAS CHANGED TO A DIFFERENT BRAND. THE EVENT RESULTED IN MINIMAL TEMPORARY HARM TO THE PATIENT AND UNEXPECTED AND/OR PROLONGED CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372364 SALTER O2 CANNULA U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING, VYNIL TI BYX SALTER LABS 001350 UNKNOWN 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown