MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MATTRESS,SYSTEM,A10,LAL/ALTERNATING

Catalog Number	MDT24A10
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "air mattress is getting deflated from center.Pump shows normal pressure but as soon as patient lies on the mattress it deflates from the center.".
Additional Manufacturer Narrative
The reported product problem/issue was does not hold air, and the complaint stated the air mattress was getting deflated from center, the pump shows normal pressure, and as soon as the patient lies on the mattress it deflates from the center.Medline was not provided the sample and was unable to confirm the complaint; the lot number is from an item that was manufactured in feb 2024, and the manufacturer has a 12 month warranty and would not consider this out of box manufacture defect but normal use wear/tear.The reported problem was unconfirmed, and the cause was documented as sample required to determine cause.There was no reported death or serious injury associated with this event, product was not being used for treatment or diagnosis, and a review of the complaint trending report found no negative trends for this defect or product code and 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: MATTRESS,SYSTEM,A10,LAL/ALTERNATING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947130
• Report Number: 1417592-2026-54397
• Device Sequence Number: 10446271
• Product Code: FNM
• UDI-Device Identifier: 10193489135671
• UDI-Public: 10193489135671
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 09/08/2026

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: MDT24A10
• Device Lot Number: M05240206
• 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: 12/10/2025
• Initial Report FDA Received Date: 09/30/2026
• 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