MAUDE Adverse Event Report: MALLINCKRODT MANUFACTURING LLC INOMAX DSIR PLUS (DELIVERY SYSTEM); NITRIC OXIDE ADMINISTRATION APPARATUS

Model Number	10007
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer located in the united states contacted (b)(6) on (b)(6) 2026 to report they experienced a no / n2 system leak with their inomax dsir plus device while a patient was receiving inhaled nitric oxide (no) therapy.The customer immediately utilized the inomax dsir plus device's inoblender to manually ventilate the patient and then replaced the dsir plus with a backup unit.The customer reported the patient remained in stable condition at the time of the event.The complaint device was returned to (b)(6) for investigation.An internal employee performed a service order review for inomax dsir (b)(6).Review of the service order determined that the no / n2 system leak was caused by a shutoff valve failure.As a result, these service order findings meet the criteria of a reportable malfunction as it was located at a user's facility and set to administer a dose of inhaled nitric oxide (no) at the time of the incident.
Additional Manufacturer Narrative
Reportable malfunction with inomax dsir plus (b)(6) was documented and investigated under (b)(4).The device was returned to a regional service center (rsc) for evaluation.The rsc also experienced the reported complaint of a no / n2 system leak during testing.Further investigation of the device found the leak was due to a shutoff valve failure.As a result, the shutoff valve was replaced, and the device passed all subsequent leak testing.The root cause for the no / n2 system leak was most likely due to a shutoff valve failure.Trends were reviewed for this reportable condition and determined to be within the established control limits.No further action is required at this time.A full functional test was performed and the device operated according to specifications.As a result, the device was placed back into circulation for customer use.

• Brand Name: INOMAX DSIR PLUS (DELIVERY SYSTEM)
• Common Device Name: NITRIC OXIDE ADMINISTRATION APPARATUS
• Manufacturer (Section D): MALLINCKRODT MANUFACTURING LLC; 6603 femrite drive; madison WI 53718
• Manufacturer (Section G): MALLINCKRODT MANUFACTURING LLC; 6603 femrite drive; madison WI 53718
• Manufacturer Contact: mark wendelken ; 440 us rt 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 25135541
• Report Number: 3004531588-2026-00023
• Device Sequence Number: 9325410
• Product Code: MRN
• UDI-Device Identifier: 00867538000106
• UDI-Public: (01)00867538000106
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K061901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown