MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL BED FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the side rail was not raised and locked at the time of the event.The device inspection revealed no malfunction.The citadel bed was functioning according to the manufacturer¿s specifications.The side rails operated correctly and could be securely locked in the raised position.The decision to use side rails depends on various factors, including the patient's risk of falling.In this case, it was reported that the patient was immobilized, and therefore the nurse did not expect the patient to fall from the bed.The citadel bed frame system instruction for use (ifu, 830.213 rev.14) 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.¿ arjo device did meet its specification since no malfunction that could lead to patient fall was found.The bed was in use by a patient, so from that perspective it played a role in the event.The complaint was assessed as reportable due to the allegation that the patient fell out of bed.
Event or Problem Description
Arjo was informed about a patient¿s fall from a citadel bed.It was reported that the side rail was not raised and latched, and the patient rolled over and fell out of the bed.A nurse stated that the patient was immobile and could not understand how the fall occurred.No injuries were reported.

• 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: 22724624
• Report Number: 3007420694-2025-00199
• Device Sequence Number: 13003690
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)170825
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/06/2025

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2017
• 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