MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED ONLY, FCE1130, HI/LOW

Catalog Number	FCE1130B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the bed is not working.The foot part of the bed will go down but not the head when using hte hi-lo function.".
Additional Manufacturer Narrative
The customer reported that the bed was "new out of box" and that "the high low for the head section will not move"; after the customer swapped the high low ports, "the head section works but the foot will not." the complaint investigation noted that no sample was received and there were no samples, photos, videos, serial numbers, lot numbers, or other critical details provided, even after follow-ups with the customer.The complaint could not be confirmed, and without a sample received, it is difficult to determine a true root cause for the reported issue.Complaints are monitored via sop-00032 trend analysis procedure, and if a sample, photo and/or additional information becomes available this complaint will be reopened to be 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 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: BED ONLY, FCE1130, HI/LOW
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50827038
• Report Number: 1417592-2026-45312
• Device Sequence Number: 10648315
• Product Code: FNL
• UDI-Device Identifier: 10888277694521
• UDI-Public: 10888277694521
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/18/2026

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: FCE1130B
• 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: 09/06/2023
• Initial Report FDA Received Date: 09/18/2026
• 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