MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LAL MATTRESS,BARI SUPRA AIR 42

Catalog Number	MDTSUPAIRB42
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it does not hold air like it should.".
Additional Manufacturer Narrative
The reported product problem/issue was that the mattress does not hold air.Medline initially noted no sample or photo had been provided, then the sample was delivered and medline confirmed that the mattress would not inflate with a pump used for evaluating mattresses; the vendor found no potential cause for any defects within their production records.The reported problem was confirmed.Medline was unable to find root cause of defect with the mattress; the cpr, quick connector and t-joins were properly connected, no leaking cells were found, and no air leaking from the mattress was heard.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.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: LAL MATTRESS,BARI SUPRA AIR 42
• 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: 50519094
• Report Number: 1417592-2026-27864
• Device Sequence Number: 21176087
• Product Code: FNM
• UDI-Device Identifier: 10197344102136
• UDI-Public: 10197344102136
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: MDTSUPAIRB42
• Device Lot Number: 250925
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2026
• 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: 03/20/2026
• 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