MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MATTRESS,SYSTEM,A20,LAL/ALTERNATING

Catalog Number	MDT24A20
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that she took it out of the box and it was not working (it was not holding air).The cells in the mattress aren¿t inflating and when they do they are not keeping the air.
Additional Manufacturer Narrative
The customer reported that the item was taken out of the box and it was not working, it was not holding air, and the cells in the mattress aren¿t inflating and when they do they are not keeping the air.The sample was received; the pump that came with the mattress was attached and the mattress did not fully inflate and the low pressure light on the pump did not turn off, then a known good pump was attached and again the mattress would not fully inflate and the low pressure light would not turn off.The reported issue was confirmed, and no holes in the mattress or issues with the connections were found.The cause was documented as cannot determine cause with received sample; a replacement was sent to the customer and the division trends the complaints quarterly.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,A20,LAL/ALTERNATING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50902454
• Report Number: 1417592-2026-51330
• Device Sequence Number: 16128815
• Product Code: FNM
• UDI-Device Identifier: 10080196549733
• UDI-Public: 10080196549733
• 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): 09/24/2026

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: MDT24A20
• Device Lot Number: 02623010214
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2023
• 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: 09/06/2023
• Initial Report FDA Received Date: 09/25/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown