MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MATTRESS,EQAIRE PLUS 12000,35X80X7, AG

Catalog Number	MDTEP123580A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connecting pipe, which holds the air, has broken and is pushed inside the mattress.
Additional Manufacturer Narrative
The customer reported that the maintenance team discovered that the connecting pipe, which holds the air, has broken and is pushed inside the mattress, and indicated the issue did not occur during use and no injury occurred.A medline canada complaint history review for the past 12 months revealed a total of 2 complaints about this sku and no previous complaints of the same reported issue; no trends of this issue with the product were identified, and no sample or photos were available.Because no sample or photos were available, the reported problem could not be evaluated for this complaint.The record states this issue is a known issue and the division is completing a design change with the vendor; no root cause was identified in the record.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: MATTRESS,EQAIRE PLUS 12000,35X80X7, AG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50914892
• Report Number: 1417592-2026-51941
• Device Sequence Number: 5369744
• Product Code: FNM
• UDI-Device Identifier: 10193489086072
• UDI-Public: 10193489086072
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/25/2026

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: MDTEP123580A
• Was Device Available for Evaluation?: No
• 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: 01/13/2026
• Initial Report FDA Received Date: 09/28/2026
• 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