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)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr summary report covers malfunction events that occurred in q2 of 2025.The report summarizes 2 malfunction events involving long term care beds (fce1232b).Customer reported that "this customer is needing replacement foot control boards for these beds.".
Additional Manufacturer Narrative
This vmsr summary report covers malfunction events that occurred in q2 of 2025.Associated serial numbers: (b)(6).Associated di: (b)(4).No lot number was available.The report summarizes 2 malfunction events involving long term care beds (fce1232b).Customer reported that "this customer is needing replacement foot control boards for these beds." sample and/or photo/video were not available; finished good/component trending was performed, pcn history was reviewed, and quality control inspection records were reviewed.The investigation results were not confirmed, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.The cause code was updated to unconfirmed defect - sample required to determine cause, and complaints are monitored via (b)(4) trend analysis procedure.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-BED ONLY,4-MOTOR,HI/LOW,34.5W
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915264
• Report Number: 1417592-2026-51979
• Device Sequence Number: 5369757
• Product Code: FNL
• UDI-Device Identifier: 40080196289067
• UDI-Public: 40080196289067
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Exemption Number: VMSR
• 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: 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: 04/24/2025
• Initial Report FDA Received Date: 09/28/2026
• 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