BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER O2 CANNULA

    MDR report key: 25107141 · Received May 6, 2026

    Report

    Report Number
    3004748541-2026-00090
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    March 20, 2026
    Report Date
    May 6, 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
    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 IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 06 MAY 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, THE PATIENT EXPERIENCED A DESATURATION EPISODE TO 70% WHEN THE OXYGEN TUBING, THAT WAS CONNECTED TO THE PATIENT'S HOME CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP), MACHINE BECAME KINKED AT TWO SEPARATE LOCATIONS AND RESTRICTED THE OXYGEN FLOW. MINIMAL TEMPORARY HARM WAS REPORTED; NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION RECEIVED ON 24APR2026 REPORTED, THE PATIENT RECOVERED POST INCIDENT AND WAS DISCHARGED FROM THE INTENSIVE CARE UNIT (ICU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178834 SALTER O2 CANNULA U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING, VYNIL TI BYX SALTER LABS 001350 573087 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1