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	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Results will be provided in the final report.
Event or Problem Description
It was reported that the patient fell out of bed.No injury was sustained.The customer indicated that the patient was trying to get out of bed.No injury was sustained.The staff claimed that at the time of the fall, the varizone movement system was on and did not sound.The bed was swapped to the service center.The bed evaluation was performed, and the patient's movement system was checked; no malfunction was found.
Additional Manufacturer Narrative
The allegation that the nurse claimed was an "exit alarm" was on, but did not sound.It should be noted that the varizone movement system detects patient¿s movements, however it will not restrain the patient from leaving the bed.The arjo beds are equipped with the side rails that can be used in accordance with site-specific policies); however, they do not eliminate the possibility of an intentional patient exit.Citadel bed frame system instruction for use (ifu, 830.213 rev.15) includes below information about patient fall risk: ¿to minimize risk of falls or injury, the bed should always be in lowest practical position when the patient is unattended.¿ ¿caregiver should always aid patient in exiting the bed.Make sure a capable patient knows how to get out of bed safely (and, if necessary, how to release the side rails) in case of fire or other emergency.¿ ifu (830.213 rev.15) also includes information about bed exit alarm and it¿s sensitivity: ¿the patient movement detection system can be set to alarm when undesired movement occurs.The sensitivity of the patient movement detection relative to the center of the deck, can be varied incrementally.¿ "the patient movement detection function should be checked periodically for correct operation and before each new patient uses the bed." ¿in bed ¿ this button activated/ deactivates patient movement detection and increases the sensitivity of the system.¿ ¿patient movement detection threshold display ¿ an indicator shows current system status and the selected sensitivity of patient movement detection.¿ ¿egress ¿ this button activates/ deactivates patient movement detection and decreases the sensitivity of the system.¿ ¿before using patient movement detection, verify that the alarm can be easily heard by caregivers.Example: at nurse¿s station.¿ the arjo device did not fail its specification since no device malfunction was found.The device was used for the patient treatment at the time of the incident.The complaint was assessed as reportable due to the allegation that the patient fell out of the bed.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: 24738966
• Report Number: 3007420694-2026-00045
• Device Sequence Number: 10264987
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)200901
• 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): 04/24/2026

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
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown