MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	FX811B3B4AMABB
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the review of previous complains, the main factor that could lead to the button being stuck might be normal wear due to age or related to an excessive force applied to the control panel (originating from the collisions with objects, such as door frames or from the bed being pressed against a different surface, such as wall).In the complaint at hand, there were no signs that the button was damaged by impact, the button was only slightly compressed.The control panel was not replaced since bed's manufacturing date (october 2020).It seems that wear due to use is the most likely cause of the button malfunction.However, due to the fact that the part was scrapped, further evaluation to determined the cause could not be performed.The citadel plus instructions for use (ifu 831.374.En) include the following information regarding regular check of the bed: "check that the patient controls, care giver controls and attendant control panels operate correctly" - weekly."carry out a full test of all electrical bed positioning functions (backrest, height, tilt, etc.)" - weekly."if the result of any of these actions is unsatisfactory, contact arjo or qualified service personnel." the citadel plus bed frame was not up to the manufacturer¿s specification due to faulty button located on the control panel.The complaint was assessed as reportable due to allegation that the bed moved on its own.There was no patient involvement, and no injuries were reported.
Event or Problem Description
During the quality control check performed at the arjo service centre, it was noted that the citadel plus bed frame moved unintentionally because the button responsible for the downward movement, located on the attendant control panel on the right-hand head-end side rail, was stuck in the activated position.There was no patient involvement.No injury was reported.

• Brand Name: CITADEL PLUS
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 24762908
• Report Number: 3007420694-2026-00052
• Device Sequence Number: 16021365
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)201030
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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
• Operator of Device: Other
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown