MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP HUDSON RCI; ISO-SHIELD CIRCUIT,INFNT,HTD DL,DRAIN

Catalog Number	HUD88015KIT
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connection point where the circuit connects to the heater was burned and melted.
Additional Manufacturer Narrative
It was reported that the connection point where the circuit connects to the heater was burned and melted.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.
Additional Manufacturer Narrative
Updated codes d9 to (b)(6)2026, h6(c) to 170, and h6(d) to 25 per final investigation.

• Brand Name: HUDSON RCI
• Common Device Name: ISO-SHIELD CIRCUIT,INFNT,HTD DL,DRAIN
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: moriah meyer ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25391746
• Report Number: 1417592-2026-02009
• Device Sequence Number: 20184650
• Product Code: OGG
• UDI-Device Identifier: 10197344010479
• UDI-Public: 10197344010479
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: HUD88015KIT
• Device Lot Number: 25-GOA728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown