MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	FX811B3B4AMABB
Medical Device Problem Codes	Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of post-market surveillance data and the investigation carried out at the manufacturer site revealed that the main factor which leads to the side rail breakage is related to an excessive force applied to the side rail.This is in line with the side rail condition (the side rail was bent) and the reported circumstances of the bed damage, the patient tried to leave the bed by climbing over raised side rails.The citadel plus instruction for use (ifu, 831.374 rev.14) includes below information: ¿side rails are not intended to restrain patients who make deliberate attempt to exit the bed.¿.¿to minimize risk of falls or injury, the bed should always be in lowest practical position when the patient is unattended.¿.¿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.¿.To sum up, arjo device failed to meet its performance specification since the side rail was bent.The device was used by a patient when this malfunction occurred.This complaint was assessed as reportable due to allegation about patient¿s fall.No injury was sustained.
Event or Problem Description
Arjo became aware of an event involving a citadel plus bed frame.The customer reported that a 430-lb patient in a state of delirium attempted to exit the bed by climbing over the side rail, despite being unable to walk.The side rail broke, and the patient fell from the bed onto the floor.An arjo service technician inspected the bed and found that the right-hand foot-end side rail was bent but still attached to the frame.No injuries were 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: 24647385
• Report Number: 3007420694-2026-00038
• Device Sequence Number: 18615635
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)200623
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/20/2026

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: 02/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• 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
• Patient Weight: 195 KG