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

Catalog Number	MDT24A20
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 2 malfunction events that occurred during q4 2025 ((b)(6) 31, 2025).The account reported that two mattress systems were going flat in the middle.The customer requested replacement of both mattresses due to loss of support in the center section.The reported condition was identified prior to any reported injury.Samples were reported as available for evaluation.The complaint was subsequently reviewed for lot information and warranty status.No patient age, weight, sex, race, or ethnicity information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 2 malfunction events that medline became aware of during q4 2025 ((b)(6) , 2025).Associated lot numbers are (b)(6) and (b)(6).Two mdt24a20 mattress systems were reported to be going flat in the middle, resulting in inadequate support performance.The customer requested replacement of both mattresses due to the reported loss of inflation in the center section.The affected units were determined to be outside of the manufacturer's warranty period based on the reported lot numbers.Records indicated that the mattresses were manufactured in december 2021 and november 2022, respectively.The product is discontinued, and the division is no longer working with the original vendor for this product code.No physical samples, photographs, videos, or additional supporting information were received for evaluation.As a result, medline quality was unable to perform visual inspection, functional testing, or detailed failure analysis of the reported condition.Based on the available information, the reported malfunction could not be confirmed, and there was insufficient evidence to determine whether the devices failed to meet specifications.Of the events summarized, 0 devices were returned for evaluation.The devices' labeled single-use status was not available, and no devices were identified as reprocessed or reused.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: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931794
• Report Number: 1417592-2026-52887
• Device Sequence Number: 10734784
• Product Code: FNM
• UDI-Device Identifier: 10080196549733
• UDI-Public: 10080196549733
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Was Device Available for Evaluation?: Yes
• 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: 11/26/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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