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

Catalog Number	HCSMONKEY
Medical Device Problem Codes	Gas Output Problem (1266); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nebulizer has no power.
Additional Manufacturer Narrative
The customer stated the nebulizer has no power.Medline quality received one unit, visually inspected the sample, observed that it was received with a clean filter, observed a rattling sound upon gently shaking the sample, plugged the sample into a power source and turned the sample on, and the sample turned on with a low humming sound and did not mist; a digital flowmeter reading was 0.0 lpm, and the piston was found to be detached.As a result, we were not able to confirm the complaint; however, there were other issues found that do confirm the product is not working properly, and the sample did not meet product specifications.The division will monitor the complaint during quarterly trending and notify the manufacturing site of the issue on a quarterly basis.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: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852976
• Report Number: 1417592-2026-47291
• Device Sequence Number: 15958990
• Product Code: BTI
• UDI-Device Identifier: 40884389106892
• UDI-Public: 40884389106892
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/21/2026

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: 6462202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2023
• 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: 06/28/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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