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

Catalog Number	MDT24A20PUMP
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿the pump does not fully inflate the mattress however does continued to run.¿.
Additional Manufacturer Narrative
The customer states the pump does not fully inflate the mattress however does continued to run.The investigation noted that the mattress was manufactured in august 2023, the warranty on this mattress is 18 months, and the customer has been using the mattress since (b)(6) 2023, so this would not be a out of box quality issue but wear/tear; the samples were not received.The defect was unable to be confirmed, and the cause was listed as sample required to determine cause.There was no reported death or serious injury associated with this event, product was not being used for treatment or diagnosis, and the investigation indicated no need for further action.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 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50545933
• Report Number: 1417592-2026-29547
• Device Sequence Number: 10266235
• Product Code: FNM
• UDI-Device Identifier: 10884389945896
• UDI-Public: 10884389945896
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/31/2026

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?: No
• 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: 04/01/2025
• Initial Report FDA Received Date: 09/01/2026
• 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