MAUDE Adverse Event Report: Medline Industries, LP HUDSON RCI; NEPTUNE HEATED HUMIDIFIER,CONCHASMART

Catalog Number	HUD42500
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device ¿will not stay on.¿.
Additional Manufacturer Narrative
The complaint description stated ¿will not stay on,¿ with the defect code text ¿turns off during use.¿ medline quality received a complaint for 1 ea and noted that the unit was not further tested; a retrospective review later determined that the complaint record does not contain sufficient documented evidence to support confirmation of the reported failure mode, and the associated sample is unavailable for evaluation.The reported problem is unconfirmed because no objective supporting evidence is present within the complaint file to substantiate a definitive failure mechanism.No specific root cause was identified; the cause code was updated to ¿unconfirmed - sample required to determine root cause,¿ and the division will monitor the complaint during quarterly trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: HUDSON RCI
• Common Device Name: NEPTUNE HEATED HUMIDIFIER,CONCHASMART
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945689
• Report Number: 1417592-2026-54121
• Device Sequence Number: 13374782
• Product Code: BTT
• UDI-Device Identifier: 10197344010806
• UDI-Public: 10197344010806
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Device Catalogue Number: HUD42500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown