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	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.The suspected part was returned to the manufacturer for further testing on (b)(6) 2025.Further information will be available after the completion of the testing and analysis performed by the manufacturer.
Event or Problem Description
The customer claimed that the bed was locked; however still it was still rising on its own.There was no indication regarding the patient's involvement.No injury was sustained.The device was swapped, and it was found that the nurse control panel located on the right-side panel had a defective up button.The button responsible for moving the bed up was stuck in the activated position.
Additional Manufacturer Narrative
There was found no signs of impact that could cause the button to be damaged.It was decided to return the part for the additional evaluation at the supplier.The test performed identified: the internal snap dome inside the switch became displaced, preventing it from returning to its neutral position.The other buttons on the same panel remained fully functional.Sum up, based on the available evidence, the unintended upward bed movement resulted from the ¿up¿ button remaining stuck in the activated position due to an internal snap-dome failure.No signs of external impact or misuse were identified.However, the definitive root cause cannot be fully confirmed, as the supplier¿s proposed explanation involving external mechanical impact is unlikely and not supported by the findings.The arjo device failed to meet its specification, as unintended bed movement occurred.The device was not in use for the patient treatment at the time of the incident.The complaint was assessed as reportable due to the allegation of unintended upward movement.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: 23531525
• Report Number: 3007420694-2025-00278
• Device Sequence Number: 13046643
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)221004
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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