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

Catalog Number	MDT24A20
Medical Device Problem Codes	Inflation Problem (1310); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there was an area that did not inflate and caused sinking where my mom¿s bed sore was.".
Additional Manufacturer Narrative
The account reported via email that there was an area that did not inflate and caused sinking where the reporter¿s mom¿s bed sore was; no report of any patient injury or adverse event was received.Medline was provided the sample, pumped the mattress up, and sprayed soapy water on the mattress; no leaking cells were found.The defect of the mattress not fully inflated was unable to be confirmed, and the cause was not confirmed with the received sample.No defect was found, corrective action type was none, 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,A20,LAL/ALTERNATING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946246
• Report Number: 1417592-2026-54205
• Device Sequence Number: 21445610
• Product Code: FNM
• UDI-Device Identifier: 10080196549733
• UDI-Public: 10080196549733
• 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): 09/29/2026

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
• Date Returned to Manufacturer: 12/04/2024
• 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: 11/08/2024
• Initial Report FDA Received Date: 09/30/2026
• 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