BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE

    MDR report key: 23600912 · Received November 19, 2025

    Report

    Report Number
    3004748541-2025-00125
    Event Type
    Injury
    Date Received
    November 19, 2025
    Report Date
    May 1, 2026
    Manufacturer
    SALTER LABS DE MEXICO DE S.A. DE C.V.
    Product Code
    NFB
    UDI-DI
    10190752117730
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    3902560000-2025-8143
    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

    H6: (APPROPRIATE TERM/CODE NOT AVAILABLE): THE DEVICE WAS RECONNECTED. 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 537838 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 19 NOV 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

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3004748541-2025-00123 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00124 FOR THE SECOND REPORT. MED SUN USER FACILITY MDR REPORT (B)(4) REPORTED: WENT TO BEDSIDE FOR MIDNIGHT CARE TIME FOR INFANT. TRACED LINES WITH PRECEPTOR AND FOUND NASAL CANNULA DISCONNECTED FROM HUMIDITY AND ON THE GROUND. CONNECTION CLEANED AND REATTACHED TO HUMIDIFIER. NO INFANT DESATURATION NOTED. I NOTIFIED NICU [NEONATAL INTENSIVE CARE UNIT] PROVIDER. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515442 AIRLIFE AIRLIFE INFANT CUSHION NASAL CANNULA 7 FOOT (2.1 M) CRUSH-RESISTANT OXYGEN TUBIN NFB SALTER LABS DE MEXICO DE S.A. DE C.V. SFT2601 537838 10190752117730

    Patients

    Seq Age Sex Outcome Treatment
    1