MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED, BASIC, FULL ELECTRIC, 450 LB

Catalog Number	MDR107003E
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head section will go up and down but the bed will not go back flat, has a raised lump in the middle.Also, stated that it appears that the footboard has dropped.
Additional Manufacturer Narrative
Per troubleshooting call with the customer, when foot spring assembly is raised, the feet are not raising and the patient is being pushed towards the top of the bed; the customer states that all of the elctronics appear to be working properly and the angle of the bed is the only issue with the bed.Sample and/or photo/video provided: not available; medline quality has yet to receive the requested information from the customer, and follow up with the customer to try and obtain the necessary information to process the complaint was unsuccessful.Investigation results: not confirmed.No root cause was identified; a formal investigation will be conducted should the customer provide medline quality with a photo, video, or a physical sample, 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, BASIC, FULL ELECTRIC, 450 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael mazeska ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50933824
• Report Number: 1417592-2026-53286
• Device Sequence Number: 9509115
• Product Code: LLI
• UDI-Device Identifier: 40080196321002
• UDI-Public: 40080196321002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/28/2026

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: MDR107003E
• 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: 10/14/2025
• Initial Report FDA Received Date: 09/29/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown