MAUDE Adverse Event Report: Arjohuntleigh Polska Sp. z o.o. CITADEL PLUS; Bed, Ac-Powered Adjustable Hospital

Model Number	FX811B3B4AMABB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo was informed about an event involving a citadel plus bed.The customer reported that a side rail had malfunctioned.No patient was involved, and no injuries were reported.
Additional Manufacturer Narrative
The device inspection and photo evidence showed that the left foot-end side rail of the citadel plus bed was damaged and partially detached from the bed frame.Screws securing the side rail to the bed frame had been pulled out, the side rail was bent, and the plastic cover concealing the side rail screws was found to be unglued.In the investigated complaint, the circumstances under which the equipment was damaged remain unknown.Based on the analysis of previous complaints and the conducted investigation, it is believed, that the most likely scenario is that the side rail detached (screws holding the panel to the metal plate had been pulled out, the side rail was bent, and the plastic cover concealing the side rail screws was found to be unglued) due to excessive external force applied.According to instruction for use citadel plus (ifu 831.374-en_15, 03/2026) safety sides shall be checked every day by a caregiver.If the malfunction is identified, arjo or qualified service personnel should be contacted.The side rail detached, therefore the arjo device did not meet the specification.The complaint was assessed as reportable due to the detachment of the side rail which can lead to a patient fall.There was no indication of the 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 ; +48()883337089
• MDR Report Key: 50943070
• Report Number: 3007420694-2026-00166
• Device Sequence Number: 21445585
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Operator of Device: Other
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2020
• 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