MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE HUDSON RCI NON-HEATED VENTILATOR CIRCUIT WITH TEMPERATURE PORT.; CIRCUIT, UNHTD, DUAL LIMB, ADULT, 72"

Catalog Number	HUD1607
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per customer, " after the vents are cleaned and set up again.We run an sst test before placing them to be used again.The circuit didn't pass the test."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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Per customer, " after the vents are cleaned and set up again.We run an sst test before placing them to be used again.The circuit didn't pass the test.".

• Brand Name: MEDLINE HUDSON RCI NON-HEATED VENTILATOR CIRCUIT WITH TEMPERATURE PORT.
• Common Device Name: CIRCUIT, UNHTD, DUAL LIMB, ADULT, 72"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25050194
• Report Number: 1417592-2026-00732
• Device Sequence Number: 21413772
• Product Code: CAI
• UDI-Device Identifier: 10197344042265
• UDI-Public: 10197344042265
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2026

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: HUD1607
• Device Lot Number: 26AOA360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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