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

Catalog Number	HUD42500
Medical Device Problem Codes	Insufficient Heating (1287); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "all 3 are just no longer heating.".
Additional Manufacturer Narrative
The customer reported having "3 hudson rci units that are in need of repair" and stated, "as far as i am aware, all 3 are just no longer heating." medline quality visually inspected the sample and found the unit in good condition; the breathing circuit, airway temperature probes, heated wire cables, concha column and concha water reservoir were connected for further testing, and the unit was plugged into a power source with a confirmed red/yellow indicator flash.The unit was powered on but immediately powered itself off; as a result, medline cannot confirm the reported complaint.The root cause cannot be identified, and the division will monitor the complaint during quarterly trending and notify the manufacturing site of the issue on a quarterly basis.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: MEDLINE
• Common Device Name: NEPTUNE HEATED HUMIDIFIER,CONCHASMART
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946785
• Report Number: 1417592-2026-54332
• Device Sequence Number: 18754962
• Product Code: BTT
• UDI-Device Identifier: 10197344010806
• UDI-Public: 10197344010806
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131912
• 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): 09/29/2026

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: 06/06/2023
• 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: 05/12/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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