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

Model Number	10007
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable malfunction with inomax dsir plus (b)(6) was documented and investigated under (b)(4).A review of the device's service log revealed that a delivery failure alarm occurred due to an apparent inter-processor link (ipl) failure between the device's monitoring processor and delivery processor.Although identified in the device's service log, the regional service center (rsc) did not experience a delivery failure alarm during testing.Keenova performed additional investigative activities and isolated the cause of the ipl failure to an anomaly associated with the dsir software communications component.The root cause for this occurrence is likely due to a latent defect identified in the device's software.Although a delivery failure alarm due to an ipl failure is an intermittent and infrequent occurrence, keenova is developing a software improvement to prevent future occurrences of ipl failures with the dsir device.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.
Event or Problem Description
A customer located in the united states contacted keenova on 28 apr 2026 to report they experienced a delivery failure alarm with their inomax dsir plus device while performing a monthly high range calibration.There was no report of patient harm associated with this event.The complaint device was returned for investigation.During a routine service log review, a keenova employee discovered that a delivery failure alarm had occurred due to an apparent inter-processor link (ipl) failure.This service log finding meets 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 event.

• 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 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 25460880
• Report Number: 3004531588-2026-00027
• Device Sequence Number: 8670777
• 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): 06/10/2026

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: 05/07/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2011
• 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