MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PUMP W/HOSE FOR EQUALIZEAIRE PLUS

Catalog Number	MDTEPPUMP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the pump is no longer blowing air.".
Additional Manufacturer Narrative
The reported issue was pump not working, and the customer replied, "the pump switch is broken.Because of this the pump will not turn on." the vendor investigated the complaint, and photos provided by the customer demonstrate that the switch was broken in a way that would have occurred in the field in some way; they found no potential cause in any of the related production records.The reported problem was confirmed as a broken switch.The updated cause code is dc: traced to user with misuse/mishandling, and the complaint information as well as the results of the investigation indicate no need for further action.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: PUMP W/HOSE FOR EQUALIZEAIRE PLUS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897615
• Report Number: 1417592-2026-50875
• Device Sequence Number: 18831819
• Product Code: FNM
• UDI-Device Identifier: 10193489085471
• UDI-Public: 10193489085471
• 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: MDTEPPUMP
• 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: 01/14/2025
• 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): 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