MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MATTRESS,SYSTEM,SUPRA AIR PRO,LAL

Catalog Number	MDTSUPAIRPRO
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 cells that have stopped inflating.
Additional Manufacturer Narrative
The customer reported stopped inflating and ¿2 cells that have stopped inflating¿; the issue did not occur during use.The customer returned the mattress only for evaluation; the pump was not returned, and the returned mattress was connected to a medline pump used for internal testing.During testing, the mattress fully inflated, the normal pressure indicator remained illuminated, and no air loss or leaking cells were identified; no quality defects were confirmed with the mattress, and medline was unable to evaluate the pump or confirm any quality defects associated with that component.The cause was not confirmed with the received sample, there was no reported death or serious injury associated with this event, and the product was not used for treatment or diagnosis.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,SUPRA AIR PRO,LAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50524006
• Report Number: 1417592-2026-28422
• Device Sequence Number: 21510194
• Product Code: FNM
• UDI-Device Identifier: 10197344102273
• UDI-Public: 10197344102273
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/31/2026

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: MDTSUPAIRPRO
• 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: 02/12/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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