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	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the side rail of the citadel plus bed frame was broken and hanging off.The arjo service technician inspected the bed and found that the left-hand foot-end side rail had detached.The lower arm of the side rail assembly had disconnected from the panel.Additionally, one of the threaded plates responsible for strengthening the side rail was partially torn off together with the 2 screws securing the plastic moulding.Photographic evidence provided confirmed the malfunctions.The patient was on the bed at the time.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.According to instruction for use citadel plus (ifu, 831.374-en rev.14) safety sides shall be checked every day by a caregiver.If the malfunction is identified, arjo or qualified service personnel should be contacted.To sum up, the side rail detached due to the external excessive force, which must first compromise the integrity of the safety side prior to breaking it.The side rail lower arm was disconnected from the panel, 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.The patient was on the bed at the time of the event.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 ; 883337089
• MDR Report Key: 24910157
• Report Number: 3007420694-2026-00061
• Device Sequence Number: 18440604
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)200521
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/17/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• 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