BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 22976096 · Received September 5, 2025

    Report

    Report Number
    3004531588-2025-00073
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    July 9, 2025
    Report Date
    October 17, 2025
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    UDI-DI
    00867538000106
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED FOR TREATMENT. THIS CASE IS BEING REPORTED AS A MDR AS THE INCIDENT WAS CONSIDERED LIFE-THREATENING. FROM THE DEVICE PERSPECTIVE, THERE WAS NO KNOWN DEVICE MALFUNCTION, AND NO DEVICE ISSUE WAS ALLEGED BY THE CUSTOMER. NO TREND WAS DETECTED FOR THE SERIAL NUMBER REPORTED IN THIS COMPLAINT. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, OXYGEN DESATURATION. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. 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.

    Additional Manufacturer Narrative · 0

    THE INOMAX DSIR PLUS DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS BOOTED UP WITH NO ALARMS PRESENT, A PRE-USE CHECKOUT WAS PERFORMED, AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE REGIONAL SERVICE CENTER (RSC) SET TO DELIVER 20PPM NO AND DURING TESTING THE DEVICE SHOWED A MONITORED VALUE OF 20PPM NO. THE MONITORED VALUES ISSUE REPORTED BY THE CUSTOMER WAS UNABLE TO BE REPRODUCED AT THE RSC. THE DSIR PLUS INOBLENDER WAS TESTED AND PASSED ALL TESTING ACCORDING TO SPECIFICATIONS. A REVIEW OF THE DEVICE'S SERVICE LOG SHOWED AN INJECTOR MODULE FAILURE ALARM OCCURRED AT THE TIME OF THE INCIDENT. A POTENTIAL CAUSE OF THE INJECTOR MODULE FAILURE ALARM WITH LOW MONITORED VALUES IS IF THE INJECTOR MODULE AS INADVERTENTLY DISCONNECTED DURING TRANSPORT OF THE PATIENT AS REPORTED BY THE CUSTOMER. THE INJECTOR MODULE WAS NOT RETURNED FOR EVALUATION. EVALUATION OF THE RETURNED DSIR PLUS DID NOT IDENTIFY ANY ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A POTENTIAL ROOT CAUSE FOR THE PATIENT'S OXYGEN DESATURATION IS DUE TO THE INJECTOR MODULE BECOMING DISCONNECTED DURING TRANSPORT; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. THE CUSTOMER REPORTED THE PATIENT'S OXYGEN SATURATION RETURNED TO BASELINE ONCE THEY UTILIZED A REPLACEMENT INOBLENDER AND RESUMED THERAPY. PER THE INOBLENDER OPERATOR'S MANUAL ON PAGE 4, THE INTENDED USE FOR THE INOBLENDER IS AS A BACK UP TO A PRIMARY INOMAX DELIVERY SYSTEM; OR FOR SHORT TERM ATTENDED USE WHEN A PRIMARY DELIVERY DEVICE CANNOT PRACTICABLY BE USED. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. ADVERSE EVENT TERM: LOW OXYGEN SATURATION (B)(4), (B)(6) 2025.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED ON (B)(6) 2025 TO REPORT AN ISSUE WITH THEIR INOMAX DSIR PLUS WHILE A PATIENT WAS RECEIVING INHALED NITRIC OXIDE (NO) THERAPY. THE CUSTOMER REPORTED THE INCIDENT OCCURRED ON (B)(6) 2025. THE CUSTOMER STATED THE PATIENT WAS BEING TRANSPORTED AND WAS BEING VENTILATED WITH HAMILTON T1 VENTILATOR AT THE FOLLOWING SETTINGS, PCV+ RR45 PC 22, PEEP +8, PIP 28, AND FIO2 AT 100%. THE DSIR PLUS WAS SET TO 20PPM AND NO ALARMS WERE PRESENT. THE PATIENT WAS RECEIVING OR HAD RECEIVED SURFACTANT (BLES) 3.5ML, AMPICILLIN 30MG, TOBRAMYCIN 1.8MG, VITAMIN K 0.5MG, CAFFEIN 7MG, D10W 3.1ML/HR. THE PATIENT WAS STABLE WITH AN OXYGEN SATURATION VIA PULSE OXIMETRY OF 87%-92%. AFTER 30 MINUTES OF TRANSPORT THE PATIENT HAD A SPONTANEOUS DECREASE IN THE PULSE OXIMETRY VALUE "INTO THE 70'S". THE CUSTOMER REPORTED THAT NO ALARMS OCCURRED ON THE INOMAX DSIR PLUS AND IT WAS OPERATING WITH SPECIFICATIONS. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND VENTILATED USING THE INOMAX DSIR DEVICE'S INOBLENDER WITH AN MIE (FLOW INFLATING BAG). THERE WAS IMMEDIATE RESPONSE AND THE PATIENT RETURNED TO BASELINE. THE STAFF RECONNECTED THE PATIENT TO THE HAMILTON T1 WITH THE DSIR PLUS AND THE PATIENT AGAIN BEGAN TO DESATURATE TO THE 50% RANGE. THE STAFF AGAIN VENTILATED WITH INOMAX DSIR DEVICE'S INOBLENDER TO CONTINUE PROVIDING INHALED NO THERAPY. THE CUSTOMER REPORTED THE STAFF ELECTED TO NOT RETURN THE PATIENT TO THE HAMILTON T1 AND MANUALLY VENTILATED THE PATIENT TO THEIR ROOM WHERE THEY WERE CONNECTED TO A REPLACEMENT INOBLENDER AND REPLACEMENT FLOW INFLATING BAG. ONCE CONNECTED TO THE REPLACEMENT INOBLENDER AND FLOW INFLATING BAG THE PATIENT RETURNED TO BASELINE. THE CUSTOMER REPORTED THE STAFF HAS SINCE UTILIZED THE SAME INOBLENDER AND DSIR PLUS FOR MULTIPLE TRANSPORT WITH NO ALARMS OR CONDITIONS NOTED. THE INOMAX DSIR PLUS WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266194 INOMAX DSIR (DELIVERY SYSTEM) NITRIC OXIDE ADMINISTRATION APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10007 00867538000106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening