MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED ONLY,4-MOTOR,HI/LOW,34.5W,LOCK

Catalog Number	FCE1385B
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on both side of bed the bolts have not completely pulled through but has started to bend tabs and widened right side hole as well.".
Additional Manufacturer Narrative
The customer stated that the bolts have not completely pulled through but have started to bend tabs and widened the right side hole, and the complaint noted a broken head motor and damage to the head deck based on attached pictures.Medline reviewed four photos; the product appeared to be in used condition, in storage and not being currently used, with a bent tab observed on the right side frame of the head deck section and the head hi-lo actuator fractured.The investigation results were confirmed.The root cause of the bent tab is unknown given the evidence provided in the complaint and photo; no product changes were identified that could have contributed to this product failure, and no corrective/preventive action was taken.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 ONLY,4-MOTOR,HI/LOW,34.5W,LOCK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50721172
• Report Number: 1417592-2026-36427
• Device Sequence Number: 10309417
• Product Code: FNL
• UDI-Device Identifier: 10888277100022
• UDI-Public: 10888277100022
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/10/2026

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: FCE1385B
• 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: 04/10/2023
• Initial Report FDA Received Date: 09/10/2026
• 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