MAUDE Adverse Event Report: Medline Medline; NEBULIZER,KIT,MASK,ADULT, 7' TUBING,SC

Catalog Number	HCS4485
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was overheating.
Additional Manufacturer Narrative
It was reported that " "after a short time of use, the nebulizer overheats and causes the mask line to be expelled due to the high temperature of the device." 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.

• Brand Name: Medline
• Common Device Name: NEBULIZER,KIT,MASK,ADULT, 7' TUBING,SC
• Manufacturer (Section D): Medline; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: muniba anwar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50927056
• Report Number: 1417592-2026-52802
• Device Sequence Number: 21514059
• Product Code: CAF
• UDI-Device Identifier: 10080196715558
• UDI-Public: 10080196715558
• Combination Product (Y/N): N
• Initial Reporter Country: PR
• PMA/510(K) Number: K091272
• 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): 09/28/2026

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: HCS4485
• Was Device Available for Evaluation?: Yes
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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