BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2 CANNULA

    MDR report key: 23175375 · Received September 29, 2025

    Report

    Report Number
    3004748541-2025-00070
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Report Date
    January 5, 2026
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    UDI-DI
    10889483605714
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 29 SEP 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: B3; D3; D9, D4. ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: D4; H2; H6. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND EVALUATED. THE REPORTED FAILURE COULD NOT BE REPRODUCED DURING TESTING USING THE SALTER LABS 7900 HUMIDIFIER AT 15LPM (IF THE PRODUCT WAS PROPERLY SEATED ON HUMIDIFIER). THE REPORTER PROVIDED A PHOTO OF THE EVENT AND IT WAS NOTED THAT THE CUSTOMER LIKELY DID NOT FULLY SEAT THE CONNECTOR ONTO THE HUMIDIFIER. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR. THE DEVICE HISTORY RECORD FOR LOT 537838 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. 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

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED SECOND DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00069 FOR THE FIRST REPORT IT WAS REPORTED- A PATIENT REQUIRED CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) AFTER A DESATURATION EPISODE DUE TO THE TUBING 'SLIPPING' OFF FOR AN UNDETERMINED AMOUNT OF TIME. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S CONDITION OR IF ANY MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED SECOND DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00069 FOR THE FIRST REPORT. IT WAS REPORTED- A PATIENT REQUIRED CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) AFTER A DESATURATION EPISODE DUE TO THE TUBING 'SLIPPING' OFF FOR AN UNDETERMINED AMOUNT OF TIME. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S CONDITION OR IF ANY MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145265 O2 CANNULA INFANT CUSHION NASAL CANNULA 7 FOOT (2.1M) CRUSH-RESISTANT OXYGEN TUBING CAT SALTER LABS SFT2601 537838 10889483605714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown