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	11/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The bed was found to be moving unintentionally at arjo service center.There was no patient involvement.No injury was claimed.The bed was rented by a customer and was replaced due to an error code that could not be cleared.There was no allegation that the bed moved unintentionally in any direction.The device was evaluated and an e300 error code was found, indicating that the button remained in the activated position for more than 90 seconds.The engineer repaired the device by replacing both head safety sides and the actuator responsible for the up/down movement.After the repair, the bed operated correctly.
Additional Manufacturer Narrative
The investigation revealed that the hi-lo actuator malfunctioned, likely causing a short circuit that triggered the error and uncommanded bed movement.Although the actuator was identified as the probable source of the issue, the exact root cause could not be confirmed because the faulty part was scrapped, making further supplier analysis impossible.The instructions for use for citadel bed (830.213-en) includes the following information: "check operation of side rails weekly" and to "carry out a full test of all electrical bed positioning functions (backrest, height, tilt, etc.) - weekly".Arjo device failed to meet its specification since the bed moved unintentionally.The device was not used for a patient treatment at the time of the event.The complaint was assessed as reportable due to the allegation that the bed moved on its own.

• 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: 23754353
• Report Number: 3007420694-2025-00307
• Device Sequence Number: 5904300
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)240617
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/09/2025

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
• 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: 11/15/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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