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

Model Number IPN049108

Device Problem Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event 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.

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 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
• Type of Device: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 12180765
• MDR Text Key: 261935776
• Report Number: 1417411-2021-00014
• Device Sequence Number: 1
• Product Code: OGG
• UDI-Device Identifier: 14026704627506
• UDI-Public: 14026704627506
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention