MAUDE Adverse Event Report: HUDSON HUMIDIFIER ADAPTOR 040; HUMIDIFIER NEBULIZER KIT

Model Number	IPN049108
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the humidifier adaptor that comes with this product was faulty.It was leaking at the top during use which resulted in having to turn it higher for the patient to be functional".Device was replaced.Unknown patient condition at time of report.
Additional Manufacturer Narrative
Qn#(b)(4).One 040 adaptor was returned for evaluation.The adaptor looks used with some dirt marks and some sticky residue on the top.The number "47" was embossed in the plastic inside the adaptor.The adaptor body was white, and the snap cap was clear.The adaptor did not have a sleeve around the whistle area, which could have caused the leak.A review of the manufacturing event log reported "broken seal gasket", "sleeve station push down cylinder not working", "snap cap jam up (2x)" and "upside down snap cap" which may have caused the issue reported.All issues were corrected, cleared, and restarted.All process parameters were within specification, all in process qa inspections were acceptable, and post-sterility and package integrity tests were acceptable.Based on the investigation performed, the reported complaint was confirmed.The root cause was manufacturing (assembly) related.A non-conformance was opened to address this issue.
Event or Problem Description
It was reported "the humidifier adaptor that comes with this product was faulty.It was leaking at the top during use which resulted in having to turn it higher for the patient to be functional".Device was replaced.Unknown patient condition at time of report.

• Brand Name: HUDSON HUMIDIFIER ADAPTOR 040
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 12180765
• Report Number: 1417411-2021-00014
• Device Sequence Number: 19066693
• Product Code: OGG
• UDI-Device Identifier: 14026704627506
• UDI-Public: 14026704627506
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: IPN049108
• Device Catalogue Number: 000-40
• Device Lot Number: 12K20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 07/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention