MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-BED,BARIATRIC,FULL ELECTRIC

Catalog Number	MDR107004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "center shaft has fallen off and unable reinstall because of this broken part.".
Additional Manufacturer Narrative
The customer stated that "center shaft has fallen off and unable reinstall because of this broken part" and "patients bed is unusable right now." a physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect can be conducted, and a functional or dimensional inspection cannot be executed via a photo.Investigation results were confirmed; after reviewing the photos it was discovered that the right adjoining hook that connects the foot section to the head section of the bed has fractured.It also appears that the frame support bar is not installed in the photo; per the manual, the frame support assemblies must be securely fastened to the bed frame before use, otherwise injury or damage may result, therefore, the issue may have been caused by customer misuse, and the division will monitor through 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,BARIATRIC,FULL ELECTRIC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50936945
• Report Number: 1417592-2026-53677
• Device Sequence Number: 9563832
• Product Code: OSI
• UDI-Device Identifier: 40080196321019
• UDI-Public: 40080196321019
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: MDR107004
• 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: 06/13/2024
• 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