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	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "head section where the \"ram\" does not move, it grinds/clicks" and residents are "cutting their feet" on the footboard brackets.
Additional Manufacturer Narrative
The customer reported that the head section where the "ram" does not move, it grinds/clicks, and video documentation indicated that residents are "cutting their feet" on the footboard brackets.A photo/video was provided, a physical sample was not provided, and only a visual review of the defect could be conducted; the video showed the head actuator was not functioning on one bed, another head actuator was loud with grinding noise, the edge of the dust cap on the right hand side of the footboard was sharp, and the hi-low actuator was not working properly on another bed.Investigation results were confirmed.The root cause of this issue is unknown, and the division will monitor through quarterly trending.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: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50757959
• Report Number: 1417592-2026-39720
• Device Sequence Number: 13071828
• Product Code: FNL
• UDI-Device Identifier: 10888277694521
• UDI-Public: 10888277694521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/02/2026

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: 02/14/2024
• Initial Report FDA Received Date: 09/14/2026
• 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