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	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Further information will be sent in the final report.
Event or Problem Description
The bed was lowering by itself.No patient involvement.No injury was claimed.
Additional Manufacturer Narrative
The device inspection revealed that the button responsible for lowering the bed frame located on the control panel on the left-hand head-end side rail was stuck in the activated position.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).At the time of the event, the bed was 4 years old.However, the left-hand head-end side rail had been replaced on (b)(6) 2025, three months prior to the investigated event.Therefore, although the buttons on the control panel are frequently used, stuck due to age was excluded.Furthermore, since there was no customer allegation indicating that the event caused damage to the bed, and no signs of mechanical damage were observed, the exact root cause of the malfunction cannot be determined.As the faulty panel was discarded, no further analysis could be performed.The citadel plus instructions for use (ifu 831.374.En rev.14) 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.Describe event or problem and initial reporter details were corrected.
Event or Problem Description
During the quality control inspection of the citadel plus bed frame, the arjo service technician found that the bed moved down unintentionally.There was no customer allegation.There was no patient involvement, and 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: 24813985
• Report Number: 3007420694-2026-00064
• Device Sequence Number: 20340386
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)220202
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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 Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown