BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE

    MDR report key: 23952221 · Received January 2, 2026

    Report

    Report Number
    3004748541-2026-00004
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Report Date
    April 3, 2026
    Manufacturer
    SALTER LABS
    Product Code
    NFB
    UDI-DI
    10190752117730
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    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 IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 02 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: E4. ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: D4; H2; H6. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; ADDITIONALLY, NO PHOTOGRAPHIC/VIDEOGRAPHIC EVIDENCE WAS PROVIDED BY THE REPORTER. IN THE ABSENCE OF A PHOTO OR VIDEO, THE COMPLAINT COULD NOT CONFIRMED; WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 556924 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 03 APR 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

    MED SUN MW REPORT MW (B)(4) REPORTED, "INFANT WAS SLEEPING IN RADIANT WARMER AND HAVING PHOTOGRAPHS TAKEN WHEN THIS RN SAW THAT INFANT BEGAN DESATURATING AND SATTING IN THE 70S. DUE TO A HISTORY OF THESE DEVICES FAILING, THIS RN IMMEDIATELY LOOKED TO SEE IF THE NASAL CANNULA HAD FALLEN OFF OF THE HUMIDIFIER AND IT HAD. NASAL CANNULA WAS RE-SECURED TO THE HUMIDIFIER. SATURATIONS IMPROVED IMMEDIATELY."

    Description of Event or Problem · 0

    MED SUN MW REPORT MW (B)(4) REPORTED, "INFANT WAS SLEEPING IN RADIANT WARMER AND HAVING PHOTOGRAPHS TAKEN WHEN THIS RN SAW THAT INFANT BEGAN DESATURATING AND SATTING IN THE 70S. DUE TO A HISTORY OF THESE DEVICES FAILING, THIS RN IMMEDIATELY LOOKED TO SEE IF THE NASAL CANNULA HAD FALLEN OFF OF THE HUMIDIFIER AND IT HAD. NASAL CANNULA WAS RE-SECURED TO THE HUMIDIFIER. SATURATIONS IMPROVED IMMEDIATELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142954 AIRLIFE AIRLIFE INFANT CUSHION NASAL CANNULA 7 FOOT (2.1 M) CRUSH-RESISTANT OXYGEN TUBIN NFB SALTER LABS SFT2601 556924 10190752117730

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA Female