MAUDE Adverse Event Report: MALLINCKRODT MANUFACTURING LLC. INOMAX DSIR; APPARATUS

Model Number	10074
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device issue with inomax dsir (b)(4).Was documented and investigation under (b)(4).A review of the device's service log revealed that a delivery failure alarm occurred due to over-delivery of nitric oxide (no) for 12 consecutive seconds.Although identified in the service log, the regional service center (rsc) did not experience a delivery failure alarm during testing.The root cause for this occurrence was likely due to a malfunctioning proportional valve.As a result, the device's proportional valve was replaced.This condition will be tracked and trended under the company's quality system.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
On (b)(6) 2019, a mallinckrodt internal employee discovered a delivery failure alarm due to over delivery for inomax dsir (b)(4) from the us.This service log finding meets the criteria of a reportable malfunction.There was no complaint alleged against this device.This match was found during routine review of preventative maintenance service logs from a device in the us.

• Brand Name: INOMAX DSIR
• Common Device Name: APPARATUS
• Manufacturer (Section D): MALLINCKRODT MANUFACTURING LLC.; 6603 femrite drive; madison WI 53718
• MDR Report Key: 8550185
• Report Number: 3004531588-2019-00048
• Device Sequence Number: 2065648
• Product Code: MRN
• UDI-Device Identifier: 00867538000113
• UDI-Public: (01)00867538000113
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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: 10074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1