MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-COMPRESSOR,NEBULIZER, CHARACTER, MON

Catalog Number	HCSMONKEY
Medical Device Problem Codes	Smoking (1585); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the nebulizer just keeps turning off- this is not working" and "one started smoking - one was turning off.".
Additional Manufacturer Narrative
The customer contact reported finding "the nebulizer just keeps turning off," and the customer is also saying the device is smoking.No sample or photo was received for the investigation, there were no deviation or non-conformance reports found that might have had an impact on this issue, and trending was reviewed with 0 additional reported complaints for this issue for the account in the past 6 months.The sample is no longer available, and due to not receiving the actual sample used, medline is not able to confirm what may have caused the issue.The cause code was "unconfirmed defect - sample required to determine cause," and the quality team will monitor this issue for trending purposes.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-COMPRESSOR,NEBULIZER, CHARACTER, MON
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896338
• Report Number: 1417592-2026-50721
• Device Sequence Number: 18831672
• Product Code: BTI
• UDI-Device Identifier: 40884389106892
• UDI-Public: 40884389106892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 09/24/2026

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: HCSMONKEY
• Device Lot Number: 6462001
• 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: 12/28/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown