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

Catalog Number	MDT24A20PUMP
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the mattressws are not staying inflated properly.They are going flat" and "when they are changing / rotating they don¿t fill correctly.".
Additional Manufacturer Narrative
The customer reported the mattresses were going flat, offenders were ending up on frames of beds and feeling the slats/metal of frames, and when changing/rotating they don¿t fill correctly.The pumps were evaluated by r&d and tested with ~190lbs of weight on the mattress on both static and alternating modes with settings at 80lbs, 160lbs, and 400lbs.No fault with the pumps was found, and the cause was not confirmed with received sample.The division trends the complaints quarterly and the rate is statistically in control for the product.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-PUMP,REPLACEMENT,A20,LAL/ALTERNATING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803421
• Report Number: 1417592-2026-43471
• Device Sequence Number: 8653031
• Product Code: FNM
• UDI-Device Identifier: 10884389945896
• UDI-Public: 10884389945896
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/17/2026

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: MDT24A20PUMP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/08/2023
• 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: 03/08/2023
• Initial Report FDA Received Date: 09/17/2026
• 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