MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; KIT, LOW BED F/ FULL ELECTRIC HMC BED

Catalog Number	MDSLOWBED
Medical Device Problem Codes	Noise, Audible (3273); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the headboard section make noise upon raising and lower.Upon multiple attempts the headboard section would not move any more.
Additional Manufacturer Narrative
The customer reported that the headboard section made noise upon raising and lowering and, upon multiple attempts, the headboard section would not move any more.Sample and/or photo/video was not available; medline quality reviewed the documentation listed in the complaint, performed account history/trending and finished good/component trending, and reviewed pcn history and quality control inspection records.The investigation results were not confirmed, and the cause was documented as sample required to determine cause.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: KIT, LOW BED F/ FULL ELECTRIC HMC BED
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50789883
• Report Number: 1417592-2026-42309
• Device Sequence Number: 16094717
• Product Code: FNL
• UDI-Device Identifier: 10080196361090
• UDI-Public: 10080196361090
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/14/2026

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: MDSLOWBED
• Device Lot Number: 10824070022
• 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: 03/26/2025
• Initial Report FDA Received Date: 09/16/2026
• 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