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

Catalog Number	MDTSUPRAAIR
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the new pump might be having some issues as it seems like my body is sinking into the mattress more than usual again.".
Additional Manufacturer Narrative
The customer reported that the new pump might be having some issues as it seems like the customer's body is sinking into the mattress more than usual again.Customer returned pump for evaluation and medline was able to attach the pump to a mattress for evaluations; the pump fully inflated the mattress and was left attached to the mattress for a week.The mattress stayed fully inflated and in normal pressure, and medline was unable to find any quality issues; this is an unconfirmed complaint.There was no reported death or serious injury associated with this event, product was not being 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,LAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joyce qiu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50525304
• Report Number: 1417592-2026-28548
• Device Sequence Number: 6000416
• Product Code: FNM
• UDI-Device Identifier: 10197344102549
• UDI-Public: 10197344102549
• 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): 08/30/2026

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: MDTSUPRAAIR
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2025
• 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: 08/06/2025
• 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