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

Catalog Number	FCE1385B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the section of the bed where the head is welded into the frame is broken.Additionally, the customer states that the control boxes for both beds are only raising the foot portion of the bed.".
Additional Manufacturer Narrative
It was reported that they have two beds with the same issue.The section of the bed where the head is welded into the frame is broken.The control boxes for both beds are only raising the foot portion of the bed.It was reported that they have two beds with the same issue.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,4-MOTOR, HI/LOW,34.5W, LOCK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: dantchi jeliazkova ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50235205
• Report Number: 1417592-2026-16650
• Device Sequence Number: 13330400
• Product Code: FNL
• UDI-Device Identifier: 10888277100022
• UDI-Public: 10888277100022
• 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): 08/13/2026

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: FCE1385B
• Device Lot Number: FCET2017020027
• 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: Not provided
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2017
• 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