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	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stuck button might have been caused by the external impact or wear of this part.Based on the complaints review and repair technician¿s device evaluation results, the control panel was in use for over 5 years and it may suggest that it could fail due to normal degradation, especially with frequent use.The instructions for use for citadel bed (830.213-en rev.F) includes the following information: ¿check that the patient controls, caregiver controls and attendant control panels operate correctly ¿ weekly¿.To sum up, the arjo device failed to meet its performance specification since the backrest was moving without any commands being given.There was no indication of the patient's involvement.The complaint was assessed as reportable due to the customer's allegation that the backrest section was moving unintentionally.
Event or Problem Description
Following the information gathered, there was an indication of an unintended movement on the citadel bed.It was reported that the backrest was elevating on its own without any buttons being pressed.The bed evaluation revealed that the control button on the safety side rail was stuck.The faulty side rail was replaced which solved the issue.There was no indication that the bed was used by a patient during the incident.

• 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: 20074965
• Report Number: 3007420694-2024-00222
• Device Sequence Number: 3075519
• Product Code: FNL
• UDI-Device Identifier: 05056097342184
• UDI-Public: (01)05056097342184(11)100521
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: 08/07/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2019
• 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