BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 25255801 · Received May 22, 2026

    Report

    Report Number
    3004531588-2026-00025
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED FOR TREATMENT. THE COMPLAINT IS REPORTABLE AS A MDR DUE TO THE OXYGEN DESATURATION DEEMED TO BE LIFE THREATENING. SERIAL NUMBER WAS NOT PROVIED, THEREFORE A TREND COULD NOT BE PERFORMED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, DELIVERY FAILURE AND OXYGEN DESATURATION. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. AT THE TIME OF THIS REPORT, THE ANALYSIS AND INVESTIGATION OF THE DEVICE IS STILL IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. ADVERSE EVENT TERM: OXYGEN DESATURATION (B)(4). AP (B)(6) 2026.

    Description of Event or Problem · 0

    ON 27-APR-2026 KEENOVA WAS NOTIFIED BY THE DISTRIBUTOR OF AN INCIDENT THAT OCCURRED INVOLVING AN UNKNOWN INOMAX DSIR SERIAL NUMBER. THE CUSTOMER REPORTED THEY BELIEVE THE DEVICE ALARMED DELIVERY FAILURE WHEN IT WAS BEING USED TO PROVIDE INHALED NITRIC OXIDE (NO) THERAPY TO A PATIENT. THIS OCCURRED WHEN THE DEVICE WAS SWITCHING FROM OHF TO VACI MODE ON THE SERVO-ASSISTED VENTILATOR. DURING THIS TIME THE PATIENT EXPERIENCED DESATURATION, THE CUSTOMER REPORTED THEY UTILIZED THE INOMAX DSIR INOBLENDER TO MANUALLY VENTILATE THE PATIENT TO RESUME NO THERAPY. CUSTOMER REPORTED THAT THE PATIENT WAS ABLE TO RECOVER. THE INOMAX DSIR DEVICE IS BEING RETURNED TO THE DISTRIBUTOR'S SERVICE CENTER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509632 INOMAX DSIR (DELIVERY SYSTEM) NITRIC OXIDE ADMINISTRATION APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening