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	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the analysis of previous complaints and the conducted inspection, the most probable root cause of the potential bed¿s unintended movement was accidental activation of the buttons on the control panel or the remote control.However, despite attempts to obtain additional information from the customer, the proposed scenario could not be confirmed.The lockout button located at attendant control panel (acp) can be used to prevent accidental activation of the buttons responsible for the bed platform movement.According to the product instruction for use (ifu 831.374-en) "function lockout can be used to prevent operation of the controls." no device malfunction that could cause unintended bed movement was found, thus the bed met its performance specification.There was no indication that the bed was in use by the patient when the issue occurred.The complaint was assessed as reportable due to an allegation that the bed frame continued to elevate, indicating potential unintended movement.No injury was reported.
Event or Problem Description
The customer reported that the citadel plus bed frame continued to elevate, indicating potential unintended movement.There was no indication of patient involvement, and no injury was reported.An arjo service technician inspected the bed, and no malfunction was found.The bed was subsequently rented to another customer, and no further complaints were received.

• 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: 25041097
• Report Number: 3007420694-2026-00071
• Device Sequence Number: 18744640
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)220110
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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