MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED, LOW FULL ELECTRIC, BASIC

Catalog Number	MDR107003ELO
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "broken pully system.".
Additional Manufacturer Narrative
The customer reported a "broken pully system" for the bed.Medline reviewed photo evidence provided by the customer; a physical sample was not provided, so only a visual review of the defect could be conducted and a functional or dimensional inspection could not be executed via a photo.The investigation results were confirmed: the product appeared to be in used condition, and the right side leg of the footboard appeared to be extended while the left had contracted, showing that the right side pulley system failed to pull the leg up.The documented cause was "dc: unknown responsible party - cannot determine cause w/received sample"; no trends were identified, no product changes were identified that could have contributed to the alleged product failure, and the division will monitor complaints 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, LOW FULL ELECTRIC, BASIC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50801090
• Report Number: 1417592-2026-43190
• Device Sequence Number: 8653447
• Product Code: LLI
• UDI-Device Identifier: 10080196546992
• UDI-Public: 10080196546992
• 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): 09/16/2026

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: MDR107003ELO
• 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: 05/01/2025
• Initial Report FDA Received Date: 09/17/2026
• 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