MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CONCHASMART CIRCUIT, ADLT, NIV, SL, HTD

Catalog Number	HUD87098KIT
Medical Device Problem Codes	Fire (1245); Melted (1385); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, "(b)(6) noticed smoke on the bed, opened the blanket and found blue tubings from the bipap on fire and melting.Bipap machine not on per rn." facility reports no injuries or impact to patient or user.
Additional Manufacturer Narrative
According to the facility, "(b)(6) noticed smoke on the bed, opened the blanket and found blue tubings from the bipap on fire and melting.Bipap machine not on per rn." facility reports no injuries or impact to patient or user.No additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• Common Device Name: CONCHASMART CIRCUIT, ADLT, NIV, SL, HTD
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23358677
• Report Number: 1417592-2025-00570
• Device Sequence Number: 8871614
• Product Code: OGG
• UDI-Device Identifier: 10197344010950
• UDI-Public: 10197344010950
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: HUD87098KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/22/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 127 KG