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	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it has an air leak and broken zipper.".
Additional Manufacturer Narrative
The customer reported that the mattress has an air leak and a broken zipper.Vendor evaluation determined the eq plus 12000 mattress is an open-system design and is not intended to retain air when disconnected from the pump; the issue of the zipper being broken has been confirmed from the photo.The reported air leak was not confirmed and was determined to be the result of a misunderstanding of the product's intended functionality; as the mattress has been in use for about 7 months, a root cause for the broken zipper would be difficult to determine and would not be an out of box quality issue, but more likely wear/tear customer use.There was no reported death or serious injury associated with this event, and a review of the complaint trending report indicated no negative trends for this defect or product code and no need for further action at this time.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: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884204
• Report Number: 1417592-2026-49958
• Device Sequence Number: 10717971
• Product Code: FNM
• UDI-Device Identifier: 10193489086072
• UDI-Public: 10193489086072
• 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): 09/23/2026

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?: 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: 07/02/2025
• Initial Report FDA Received Date: 09/24/2026
• 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