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

Model Number	CX811A3F3AMAB0
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a quality control inspection performed after the citadel bed frame was returned from the customer, an arjo service technician observed that the bed moved into the chair position without any command being given.There was no patient involvement.No injury was reported.The left-hand head-end safety side had a defective auto-chair button on the control panel.The issue was resolved by replacing the side rail.
Additional Manufacturer Narrative
At the time of the event, the bed was nearly six years old, and a review of the service history of the claimed device showed that the control panel had not been replaced.However, prior to delivery to the customer, the bed underwent a quality control check on 14th may 2026 and was confirmed to be functioning as intended, with no malfunctions observed.The unintended bed movement was identified on 28th may 2026 during a quality control check performed after the bed was returned from the customer.Therefore, normal wear can be reasonably excluded as the root cause, as the device was confirmed to be fully functional before delivery to the customer.Although there was no customer allegation and the circumstances under which the compression occurred remain unknown, the timing of the event (2 weeks after the quality control inspection, and after the return from the customer), together with the condition of the button, suggests that excessive force may have been applied to the control panel during use at the facility.This is consistent with post-market surveillance data, which indicates that a button becoming stuck in the activated position may result from mechanical damage caused by impact (e.G.Hitting an obstacle during use) or the application of excessive force during operation.Therefore, user error is considered the most probable contributing factor to the event.Alternatively, the damage to the control panel may have occurred during transport, for example as a result of impact with an obstacle during loading.However, arjo staff are trained in proper loading and transportation procedures.Therefore, this scenario was excluded as the root cause of the reported malfunction.The citadel bed frame system instruction for use (ifu 830.213-en_15) instructs to: "carry out a full test of all electrical positioning functions (backrest, height, tilt, etc.)" weekly, "check that the patient controls, care giver controls and attendant control panels operate correctly" weekly.If the result of any of these actions is unsatisfactory, contact arjo or qualified service personnel." to avoid device damage, the ifu warns: "when the bed is operated, make sure that obstacles such as feet, oxygen bottles, bedside furniture or any other objects do not restrict its movement." arjo device failed to meet its performance specification since the bed moved unintentionally.There was no patient involvement.No injury was reported.The complaint was deemed reportable due to allegation about unintended bed movement.

• Brand Name: CITADEL BED FRAME
• 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: 25618966
• Report Number: 3007420694-2026-00108
• Device Sequence Number: 21386919
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)200915
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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