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	04/06/2026
Type of Reportable Event	Malfunction
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 rails detached (screws holding the panel were ripped off) due to excessive external force applied.According to the instructions for use for citadel plus bed (ifu 831.374 rev.14), the operation of the sides rails should be checked daily."if the result of any of these actions in unsatisfactory, contact arjo or qualified service personnel." to sum up, the side rails detached from the bed's frame, therefore the arjo device did not meet the specification.The complaint was assessed as reportable due to the side rail panels detachment from the bed which may result in the patient fall from the bed.There was no patient involvement.No injury was reported.
Event or Problem Description
During the pick-up of the citadel plus bed frame from the customer, it was found that the left-hand foot-end side rail detached from the bed frame, the screws securing the panel to the metal plate were ripped out.Additionally, the right-hand foot-end side rail was damaged, the tape (seal) between the side rail panel and the side rail mechanism was pulling off.There was no indication of patient involvement, and 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: 25067424
• Report Number: 3007420694-2026-00076
• Device Sequence Number: 10735477
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)220124
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 04/06/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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