BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE

    MDR report key: 22693019 · Received August 1, 2025

    Report

    Report Number
    8030673-2025-01035
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 1, 2025
    Manufacturer
    AIRLIFE
    Product Code
    OGG
    UDI-DI
    10190752158450
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. 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 01 AUG 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 TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030673-2024-01036 FOR THE SECOND REPORT. IT WAS REPORTED AFTER THE RESPIRATORY THERAPIST (RT) ESTABLISHED THE UNIT ON THE PATIENT IN THE INTENSIVE CARE UNIT (ICU), THE NURSE NOTICED THE PATIENT'S OXYGEN (O2) SATURATION DROPPED. THE RT WAS CALLED AND THE DEVICE WAS REMOVED AS THE PATIENT WAS STRUGGLING TO BREATHE AND THEIR SATURATIONS WERE SO LOW THEY HAD TO BE INTUBATED. IT WAS ADDITIONALLY REPORTED, THE PATIENT EXPERIENCED AN UNSPECIFIED LIFE THREATENING INJURY; NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205454 AIRLIFE PREFILL NEBULIZER KIT OGG AIRLIFE CK0010 004298169 10190752158450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other