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

Model Number	10007
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A delivery failure alarm due to a main supply voltage below tolerance was identified by a internal employee during a routine service log review.Further review of the service log determined that a low battery alarm did not occur prior to the delivery failure alarm.As a result, these service log 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.This device was located in the united states when the reportable malfunction occurred.There was no delivery failure alarm complaint or report of patient harm associated with this incident.
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 the main supply voltage being out of tolerance (valid range: 2435 to 4075 counts, actual value: 2431 counts).Further review of the device's service log determined that a low battery alarm did not occur to prompt the user to plug the device into a power source.A low battery alarm should have occurred prior to the delivery failure alarm to prevent the out of tolerance main supply voltage condition.The regional servicecenter (rsc) did not experience a delivery failure alarm without a low battery alarm during testing of the returned device on battery power.The root cause for this occurrence was determined to be battery fuel gauge drift.As a result, the device's battery was replaced.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 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 24547572
• Report Number: 3004531588-2026-00012
• Device Sequence Number: 9385727
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 02/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2012
• 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