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	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the citadel plus bed is damaged.The arjo service technician inspected the bed and found that the right-hand foot-end side rail detached.The screws holding the panel to the metal plate were ripped off.Moreover, parts of the side rail assembly were affected, the upper arms were disconnected from the side rail panel, the lower arm was cracked, pivot pins were bent and bearing plates broken.The photographic evidence provided confirmed malfunctions.There was no indication of the patient involvement.No injury was reported.
Additional Manufacturer Narrative
The investigation is ongoing.Results will be provided in the final report.

• 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: 50800816
• Report Number: 3007420694-2026-00161
• Device Sequence Number: 8652946
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 07/16/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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