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	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse stated the bed was rising by itself, and the bed showed the error code e300.There was no indication of the patient's involvement.No injury was claimed.The bed was swapped for further evaluation at the arjo service center.The bed evaluation identified the issue with the stucked up - button on the attendant control panel located on the right head safety side.The whole safety side was replaced.
Additional Manufacturer Narrative
The investigation is ongoing.Further information will be provided in the next report.
Additional Manufacturer Narrative
The instructions for use for citadel bed (ifu, 830.213-en rev.15) includes the following information: ¿check that the patient controls, caregiver controls and attendant control panels operate correctly, weekly¿.In summary, the review of complaints and device inspection results indicate that the control panel button failure (stuck button) found during inspection might have led to the observed unexpected bed movement.The device was manufactured in 2021 and was used as a rental device.It is concluded that the issue might be related to the device's frequent use, however the part was scrapped, therefore the exact cause of the issue could not be identified.Arjo device failed to meet its specification when the bed was moving unintentionally.Arjo device was not used for a patient treatment when the event occurred.The complaint was assessed as reportable due to the allegation that the bed was moving up unintentionally.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: 23655997
• Report Number: 3007420694-2025-00296
• Device Sequence Number: 20026330
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)210201
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown