MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MATTRESS,SYSTEM,SUPRA APL,LAL/ALT. P

Catalog Number	MDT24SUPRAAPL
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "mattress does not hold air." it was also reported that "the top mattress baldders is not inflating.".
Additional Manufacturer Narrative
The customer reported that the mattress does not hold air and that the top mattress baldders is not inflating.The sample provided was only the pump, which was attached to a mattress used for testing; the mattress was fully inflated and the green normal pressure light stayed on even with added 175lbs of weight.Medline was unable to find any quality defects with the pump, and the cause was not confirmed with the received sample.No root cause was identified; there was no reported death or serious injury associated with this event, and there has been no change to the reportability decision associated with this complaint.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: DBD-MATTRESS,SYSTEM,SUPRA APL,LAL/ALT. P
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913248
• Report Number: 1417592-2026-51793
• Device Sequence Number: 17641990
• Product Code: FNM
• UDI-Device Identifier: 10080196372164
• UDI-Public: 10080196372164
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: MDT24SUPRAAPL
• Device Lot Number: 02623110126
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/18/2024
• 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: 11/04/2024
• Initial Report FDA Received Date: 09/28/2026
• 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