MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; COMPRESSOR,NEBULIZER,AEROMIST, ADLT MASK

Catalog Number	HCS70004ADLT
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported there is no "air coming out of the nebulizer" when it is turned on.Medline quality received one sample, visually inspected the sample and observed that the filter and filter cap are missing; the sample turned on and didn't mist, a digital flowmeter reading was 1.08 lpm, which does not meet product specifications, and debris was observed after the sample was opened.The reported problem was confirmed.Based on the complaint details, the root cause is most likely attributed to improper handling of the unit; there has been no change to the reportability decision associated with this complaint, and the division will monitor for trends.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.
Event or Problem Description
It was reported that nebulizer does not work properly as intended; there is no air that comes out of the product at all when turned on.

• Brand Name: MEDLINE
• Common Device Name: COMPRESSOR,NEBULIZER,AEROMIST, ADLT MASK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50275764
• Report Number: 1417592-2026-17913
• Device Sequence Number: 10379222
• Product Code: BTI
• UDI-Device Identifier: 10888277703759
• UDI-Public: 10888277703759
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 08/17/2026

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: HCS70004ADLT
• Device Lot Number: 6462303
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2024
• 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: 03/28/2024
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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