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

Catalog Number	HUD88015KIT
Medical Device Problem Codes	Material Discolored (1170); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, on (b)(6) 2026, the circuits were being used on neonatal patients requiring respiratory support in critical care, including intubation and noninvasive positive pressure ventilation.The heater portion began alarming "low temp" and upon investigation, the circuits were found melted and turning black at the connection feeding to the heater.The heater was turned off, unplugged, and the circuit was removed and replaced.The facility reports no medical intervention or treatment required for the patients, they are in "stable condition." no additional information at this time.
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, the circuits were being used on neonatal patients requiring respiratory support in critical care, including intubation and noninvasive positive pressure ventilation.The heater portion began alarming "low temp" and upon investigation, the circuits were found melted and turning black at the connection feeding to the heater.The heater was turned off, unplugged, and the circuit was removed and replaced.The facility reports no medical intervention or treatment required for the patients, they are in "stable condition." no additional information at this time.It has been determined that the reported event could cause or contribute to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: ISO-SHIELD CIRCUIT,INFNT,HTD DL,DRAIN
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 25060148
• Report Number: 1417592-2026-00839
• Device Sequence Number: 18498528
• Product Code: OGG
• UDI-Device Identifier: 10197344010479
• UDI-Public: 10197344010479
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: HUD88015KIT
• Device Lot Number: 25DOA334
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 2 KG