MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-BED ONLY,4-MOTOR,HI/LOW,34.5W

Catalog Number	FCE1232B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bed does not go up or down and the remote does not work.
Additional Manufacturer Narrative
It was reported that a hi/low bed would not raise or lower and that the hand control was nonfunctional.The customer reported having owned the bed for several years.Follow-up requests were made to obtain additional information, including photo/video/sample; however, no additional information was provided.The reported issue could not be confirmed.Quality inspection records review showed the unit passed inspection.A review of the last three trend reports identified no adverse trends for the reported defect type or material number.No product changes were identified that could have contributed to the reported issue.Medline was unable to determine a root cause.Should additional information/photo/sample become available, the complaint will be reopened, reevaluated, and further investigated.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 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-BED ONLY,4-MOTOR,HI/LOW,34.5W
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896861
• Report Number: 1417592-2026-50772
• Device Sequence Number: 10705690
• Product Code: FNL
• UDI-Device Identifier: 40080196289067
• UDI-Public: 40080196289067
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/24/2026

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: FCE1232B
• 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: 09/26/2025
• Initial Report FDA Received Date: 09/25/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown