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	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
At the time of collection of the citadel plus bed frame from the customer, the arjo service technician observed that the left-hand foot-end side rail was detached from the bed frame (the lower arm had been pulled out at one attachment point).Photographic evidence provided confirmed the malfunction.No patient was involved and no injuries were reported.
Additional Manufacturer Narrative
In the investigated complaint, the circumstances under which the equipment was damaged remain unknown.However, based on the analysis of the previous complaints and the conducted investigation, it is believed, that the most likely scenario is that the side rail detached (lower arm was disconnected) due to excessive external force applied.The instructions for use for citadel plus bed frame (ifu 831.374_en rev.15) includes information: ¿caregiver should always aid patient in exiting the bed.Make sure a capable patient knows how to get out of bed safely (and, if necessary, how to release the side rails) in case of fire or other emergency.¿ moreover, 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 lower arm was disconnected from the panel, therefore the arjo device did not meet the specification.There was no indication that the bed was in use by a patient at the time of the event.The complaint was assessed as reportable due to the detachment of the side rail which can lead to a patient fall.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: 50911740
• Report Number: 3007420694-2026-00165
• Device Sequence Number: 20284536
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• 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
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2019
• 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