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

Catalog Number	MDR107003L
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have a hospital bed with a broken foot motor" and "foot motor worm gear has broken, allowing the foot section to drop.Motor continues to run, but motor shaft does not move.".
Additional Manufacturer Narrative
The customer reported two beds with the same issue and stated that the foot motor makes noise but will not move; the customer form stated, "foot motor worm gear has broken, allowing the foot section to drop.Motor continues to run, but motor shaft does not move." medline received 2 each of bed "actuators only" in used condition, and when bench tested with known working components, the motors did work but a grinding sound from inside was heard; there was no damage to the motor case, power cord, or plug end.The investigation results were confirmed, and the result of the pic testing was functional defect.A definitive cause was not determined with the received sample; the grinding sound may be due to stripped internal gears, 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, FULL ELECTRIC, MEDLITE, 450 LB
• 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: 50873009
• Report Number: 1417592-2026-49410
• Device Sequence Number: 9223663
• Product Code: FNL
• UDI-Device Identifier: 40080196294344
• UDI-Public: 40080196294344
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: MDR107003L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2024
• 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: 09/12/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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