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

Model Number	10007
Medical Device Problem Codes	Failure to Recalibrate (1517); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine service log review for a device located in canada, an internal employee discovered that a delivery stopped alarm had occurred due to a nitric oxide (no) concentration greater than 100 ppm followed by a failed low no sensor calibration.This service log finding meets the criteria of a reportable malfunction.There was no delivery stopped alarm complaint or report of patient harm associated with this event.
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 stopped alarm occurred as the monitored nitric oxide (no) value (i.E., actual value: 108 ppm) was greater than the absolute max of 100 ppm for 12 consecutive seconds.Afterwards, a service log entry for a failed low no cell calibration due to the low points being greater than the maximum value (max: 655 counts; actual value: 990 counts) was observed.Although identified in the service log, the regional service center (rsc) did not experience a delivery stopped alarm during testing.The root cause for this occurrence was likely due to a malfunctioning no sensor.As a result, the device's no sensor 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
• Manufacturer (Section G): MALLINCKRODT MANUFACTURING LLC; 6603 femrite drive; madison WI
• Manufacturer Contact: mark wendelken ; 440 us route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 23957665
• Report Number: 3004531588-2026-00001
• Device Sequence Number: 5625923
• 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): 01/05/2025

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: 11/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2015
• 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