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

Catalog Number	MDT24A10
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "low pressure light keeps coming on and it doesn't turn back on for 20 minutes, so you don't hear air or mattress filling up" and is causing "alarm issues." the customer contact stated, "the mattress sinks in the middle when his wife is on the mattress.".
Additional Manufacturer Narrative
It was reported, "low pressure light keeps coming on and it doesn't turn back on for 20 minutes, so you don't hear air or mattress filling up" and is causing "alarm issues." the customer contact stated, "the mattress sinks in the middle when his wife is on the mattress." per the customer contact, "no injury" occurred as a result of the reported product problem and no follow-up care, medical intervention, or treatment was reported related to the reported product problem.The customer contact reported the user of the device "had passed away" and a replacement was no longer needed.The cause and date of death were not provided and despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Information received to-date has been evaluated and it was determined the subject product did not reasonably cause or contribute to the reported death.No additional details are available related to the customer reported issue.There were no reports of death, serious injury, medical intervention, or follow-up care related to the reported product problem.It has been determined that the event did not involve a death or serious injury related to the product problem; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: DBD-MATTRESS,SYSTEM,A10,LAL/ALTERNATING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898220
• Report Number: 1417592-2026-10397
• Device Sequence Number: 5829448
• Product Code: FNM
• UDI-Device Identifier: 10193489135671
• UDI-Public: 10193489135671
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 250525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (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: 84 YR
• Patient Sex: Female