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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the bed pick-up the arjo representative found the bed right body safety side completely ripped off.There was no indication that the bed was used for treatment at that time.No injury was sustained.The arjo representative during the bed pick-up found that the safety side mounting screws were completely ripped off resulting in panel detachment from the frame.The device was swapped, and the bed was repaired.
Additional Manufacturer Narrative
It is unknown under what circumstances the head side panel detached from the metal bed frame.According to the information received, the facility did not provide any details regarding the event.According to the instruction for use for citadel bed (ifu, 830.213): "check operation of the safety sides daily." the review of post-market surveillance data revealed that the main factor that could lead to the side rail damage might be related to an excessive force applied to the side rail (eg.Collision with the door).This is in line with the side rail condition, it was mechanically damaged (the safety side mounting screws were completely ripped off, resulting in panel detachment from the frame).The circumstances in which the event occurred are not known, however the analysis of the complaints indicated that the external excessive force must first compromise the integrity of the safety side prior to breaking it.Arjo device failed to meet its specification due to malfunction reported.There is no indication that the device was used for the patient's treatment when the event occurred.The complaint was assessed as reportable due to the safety side detachment from the frame.No injury was 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: 23656007
• Report Number: 3007420694-2025-00299
• Device Sequence Number: 20026331
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)170421
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown