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

Catalog Number	HCS70004
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 2 malfunction events that occurred during q3 2025 (july 1, 2025, through september 30, 2025).The account reported that two hcs70004rd nebulizers, identified by serial numbers (b)(6), were not working as intended.The customer requested replacement of both devices; however, no specific description of the malfunction was initially provided.Additional information was requested to further characterize the reported issue, and the affected devices were returned for evaluation.The customer indicated that the devices were believed to be covered under a five-year warranty.No patient age, weight, sex, race, or ethnicity information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 2 malfunction events that medline became aware of during q3 2025 (july 1, 2025, through september 30, 2025).Associated serial numbers are (b)(6).Associated lot numbers are 6462112 and 6462310.Two hcs70004 nebulizers were returned for evaluation following reports that the devices were not working as intended.For serial number (b)(6), the unit was received in used condition with a new filter and filter cap.Functional testing demonstrated that the device powered on but did not produce mist.Flow testing measured 3.7 lpm, which did not meet product specifications.Internal examination identified fluid damage and light debris.Based on the complaint details and sample evaluation, the reported issue was confirmed, and the device was determined to have failed to meet specifications.Vendor investigation did not identify a manufacturing-related cause and concluded that the compressor sealing ring was worn.For serial number 6462310042141, the unit was received in used condition with a used filter and filter cap.Functional testing demonstrated that the device powered on, produced mist, and achieved a flow rate of 7.8 lpm, which met product specifications.Internal examination identified fluid damage and a large amount of debris.Based on the evaluation, the reported issue could not be confirmed, and the device was determined to meet specifications at the time of testing.Of the events summarized, 2 devices were returned for evaluation.The devices were not labeled for single use, and no devices were identified as reprocessed or reused.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: COMPRESSOR,NEBULIZER,AEROMIST COMPACT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946458
• Report Number: 1417592-2026-54262
• Device Sequence Number: 15836360
• Product Code: BTI
• UDI-Device Identifier: 00884389106870
• UDI-Public: 00884389106870
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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
• Device Catalogue Number: HCS70004
• 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: 07/28/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown