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)
Type of Reportable Event	Malfunction
Event or Problem Description
At the time of the inspection of the citadel bed frame returned from the customer, an arjo service technician found that the button responsible for the backrest upward movement, located on the attendant control panel (acp) on the right-hand foot-end side rail, was stuck in the activated position.There was no patient involvement, and no injury was reported.
Additional Manufacturer Narrative
According to the arjo service technician, he backrest section moved upward unintentionally until it reached its highest position.Pressing another function button would temporarily override the backrest up command and perform the selected function.However, as soon as the other button was released, the backrest would continue moving upward.Based on the supplier investigation, a possible failure mechanism is that the internal metal snap dome within the switch became displaced, preventing the button from returning to its neutral position.The most likely cause is deterioration of the switch components due to long-term use and repeated button actuations over the lifetime of the device.Excessive external force (originating from the collisions with objects, such as door frames or from the bed being pressed against a different surface, such as wall) was considered as an alternative cause.However, the arjo service technician found no signs of impact or other external damage of the attendant control panel that could have caused the button to malfunction.Therefore, excessive force was excluded as a contributing factor.At the time of the event, the bed was more than 9 years old.A review of the service history in trackwise confirmed that the control panel had not been replaced previously.Therefore, the most probable root cause of the event is normal wear of the control panel due to age and repeated use.Since the faulty control panel was discarded, no further analysis could be performed.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." arjo device failed to meet its performance specification since the backrest section of 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 ; +48()883337089
• MDR Report Key: 50708357
• Report Number: 3007420694-2026-00159
• Device Sequence Number: 13278427
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2017
• 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