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

Catalog Number	MDR107002E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plastic shell of the motor is cracked and completely broken.It's not working at all.
Additional Manufacturer Narrative
The customer reported a broken motor box and stated that the plastic shell of the motor was cracked and completely broken and not working at all.A physical sample was not provided; a photo/video depicting the defect was provided and only a visual review of the defect could be conducted, and the photo showed the head end of the bed motor box with the end fractured off and the housing where the actuator bar connects to the head motor fractured, exposing the head actuator.Investigation results were confirmed.Given the evidence provided in the photo, the root cause of this issue is unknown; no corrective/preventive action was taken, 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: DBD-BED,BASIC, SEMI ELECTRIC, 450 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joyce qiu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947078
• Report Number: 1417592-2026-54388
• Device Sequence Number: 10348719
• Product Code: LLI
• UDI-Device Identifier: 40080196320999
• UDI-Public: 40080196320999
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/21/2026

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: MDR107002E
• Was Device Available for Evaluation?: No
• 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: 01/22/2024
• Initial Report FDA Received Date: 09/30/2026
• 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