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 Codes	Fall (1848); Laceration(s) (1946)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient fell out of bed.A minor head laceration was sustained.No medical intervention was required.The injury was assessed by a clinical specialist as a non-serious injury.The allegation that the nurse claimed was an exit alarm malfunction.The bed exit alarm (varizone movement system) was not working properly.The technician decided to reset the bed by pulling all of the cables including the main power to the cu20 controller, and then unplugged the bed from the main power waited about thirty seconds, and plugged it back in.
Additional Manufacturer Narrative
It should be noted, varizone movement system (bed alarm) detects patient¿s movements, however it will not restrain the patient from leaving the bed.The reason why the patient exited the bed remains unknown.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 its 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¿.To sum up, the alarm detects patient¿s movements but it will not restrain the patient from leaving the bed.Arjo device failed to meet its specification since the alarm needs to be reset.The device was in use by a patient during that time, however, the alarm issue did not cause or contributed to the patient's fall.The complaint was assessed as reportable due to the allegation that the patient fell out of the bed.A minor laceration on the patient's head was claimed.

• 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: 24208569
• Report Number: 3007420694-2026-00015
• Device Sequence Number: 9625047
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)210915
• 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): 01/29/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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