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

Catalog Number	MDT24A20PUMP
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "new pump failure out of the box today.Pump does not work.".
Additional Manufacturer Narrative
The reporter stated that this was for a pump only with no mattress and the replacement pump only does not work out of the box; failure out of the box/does not work or turn on.Upon evaluation of the pump sent in, it was confirmed that it was defective in that it would not turn on, with no visual damage or obvious reason for the pump not to turn on.The cause was documented as cannot determine cause w/received sample.The complaint trending report for the last 6 months indicated a pump failure out of the box was an isolated issue, 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 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50885366
• Report Number: 1417592-2026-50183
• Device Sequence Number: 9939383
• Product Code: FNM
• UDI-Device Identifier: 10884389945896
• UDI-Public: 10884389945896
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/23/2026

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
• Device Lot Number: 02622100186
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/09/2024
• 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: 12/28/2023
• Initial Report FDA Received Date: 09/24/2026
• 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