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

Catalog Number	MDT24A10
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that mattress wasn't holding air.
Additional Manufacturer Narrative
It was reported that the patient's daughter called to inform us the low air loss mattress wasn't holding air.She checked the cpr valve, and connections.Hearing noise from the pump and showing low pressure displayed.Upon technician diagnosis powered lal has a hole in one of the valves.Patient's family had a maintenance man tape the valve but mattress is still not holding air.Also, it was further explained that a technician went out and inspected the lal and found a hole in one of the valves.Informed us that the family had a maintenance man attempt to tape the valve but mattress is still not holding air.Also still showing low pressure alarm.The technician is going back out to replace the mattress and pump.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.

• Brand Name: MEDLINE
• Common Device Name: DBD-MATTRESS,SYSTEM,A10,LAL/ALTERNATING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -279
• Manufacturer Contact: gregory gohl ; three lakes drive; northfield, IL 60093--279
• MDR Report Key: 50899075
• Report Number: 1417592-2026-10390
• Device Sequence Number: 17648851
• 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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDT24A10
• Device Lot Number: 260430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 190 LB