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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer claimed that the bed was going up on its own.There was no indication regarding patient involvement.No injury was claimed.The bed was swapped and the device testing was performed.The service center did not find any issue with the bed.The alleged scenario was not duplicated.
Additional Manufacturer Narrative
The review of previous complaints revealed that if no device failure is detected, the bed's movement may be caused by the unintentional activation of the buttons on the control panel.This hypothesis could not be confirmed due to its nature.The instruction for use (ifu) for citadel bed (830.213-en) contains information that the caregiver should check that the patient controls, caregiver controls and attendant control panels operate corectly weekly.Also ifu includes information about function of lock-outs: "lock-outs - lock-outs for bed functions should be used at staff's discretion to prevent unintentional operation of bed." the arjo device did not fail a specification since no malfunction could have contributed to the alleged movement of the bed.The device was not used for the patient's treatment when the issue occurred.The complaint was assessed as reportable due to the allegation that the bed was moving without any commands being given.No injury was sustained.

• 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: 24159323
• Report Number: 3007420694-2026-00011
• Device Sequence Number: 21114538
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)170323
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/23/2026

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: 01/13/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2017
• 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