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

Catalog Number	HUD42500
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
No water alarm, not clearing.
Additional Manufacturer Narrative
The complaint description was "no water alarm, not clearing," and the investigation states that the unit "won¿t stop alarming." medline quality received the complaint, the sample was received, and "due to the validated service issue, the unit was not further tested"; a retrospective query found similar complaint(s).The retrospective query states, "we can confirm the reported complaint with the query," while the complaint cause was documented as "not confirmed with received sample." no root cause was identified, 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: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946440
• Report Number: 1417592-2026-54257
• Device Sequence Number: 9534267
• Product Code: BTT
• UDI-Device Identifier: 10197344010806
• UDI-Public: 10197344010806
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 08/14/2023
• 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: 07/13/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (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