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

Model Number	CX611B3F4AMAB0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional testing, using random samples, were conducted to simulate the reported situation when side rail opens when a load is applied.It was found that once the side rail is lifted to an upper, close position, it remains securely lock.The unexpected opening is unlikely.Another simulation showed that when a blue release lever (which is used to open a side rail), is pulled quickly and forecefully, the locking pin may move out of its position into the chamfered area.In that situation, the side rail remains in raised position but is not locked.Instructions for use states "pull the blue release lever and lower the side rail, holding the side rail until it is completely lowered".To sum up, the side rail could open unexpected, due to the locking pin moving out of its intended position, after the blue release lever was pulled.The side rail opened unexpectedly, therefore the arjo device failed to meet its performance specification.The device was used for patient treatment and therefore played a role in the event.The complaint was assessed to be reportable due to the allegation that the patient fell out of the bed, when the safety side allegedly released under the load of the patient.No injury was sustained.
Event or Problem Description
Arjo became aware of the event involving the citadel bed frame.The facility reported a patient fell out of bed during a turning maneuver.Allegedly the left side rail appeared to be broken, became unlocked and went down.No injury was sustained.The arjo service technician inspected the device and found no malfunction in the side rail locking mechanism.

• 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: 22737326
• Report Number: 3007420694-2025-00198
• Device Sequence Number: 12543988
• Product Code: FNL
• UDI-Device Identifier: 05056097342184
• UDI-Public: (01)05056097342184(11)190916
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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: CX611B3F4AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2019
• 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