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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of post-market surveillance data revealed that the main factor that could lead to the side rail detachment might be related to an excessive force applied to the side rail, which is in line with the side rail condition.According to the instruction for use for citadel bed (ifu, 830.213-en rev.14): "check operation of the safety sides daily." arjo device failed to meet its specification when the safety side was detached from the mounting point.The device was not used for the patient's treatment when the event occurred.The complaint was assessed as reportable due to the allegation that the safety side was detached from the frame (screws were partially ripped off).No injury was claimed.
Event or Problem Description
It was claimed by a customer that the safety sides were broken and had electrical problems.There was no indication regarding the patient involvement.No injury was claimed.It was established that one of the safety sides was detached from the frame, and the screws attaching the panel to the frame were partially ripped off.The second replaced safety side had an electrical problem- the issue is not considered safety-related.

• 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: 21467769
• Report Number: 3007420694-2025-00058
• Device Sequence Number: 12949150
• Product Code: FNL
• UDI-Device Identifier: 05056097342184
• UDI-Public: (01)05056097342184(11)190523
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/26/2025

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
• Device Model Number: CX611B3F4AMAB0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2019
• 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