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

Catalog Number	MDT24A10
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿the mattress was not staying inflated and that it would slowly lose air.¿ it was also reported that ¿the pump was showing the green light for normal pressure, but once he got in bed it would eventually light up for low pressure and it wouldn¿t return to normal pressure.¿.
Additional Manufacturer Narrative
The reporter stated the customer was having issues with the mattress, and that the mattress was not staying inflated and would slowly lose air; the pump was showing the green light for normal pressure, but once he got in bed it would eventually light up for low pressure and it wouldn¿t return to normal pressure.Medline requested the sample, but the sample was not provided; the last three quarters of complaint trending reports were reviewed.The complaint was unable to be confirmed, and the cause was listed as sample required to determine cause.There was no reported death or serious injury associated with this event, the product was not used for treatment or diagnosis, and a review of trending data indicates no negative trends associated with this defect or product code; based on these findings, no further action is required 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,SYSTEM,A10,LAL/ALTERNATING
• 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: 50915627
• Report Number: 1417592-2026-52022
• Device Sequence Number: 17586679
• Product Code: FNM
• UDI-Device Identifier: 10193489135671
• UDI-Public: 10193489135671
• 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: MDT24A10
• 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: 01/30/2026
• 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