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	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of post-market surveillance data revealed that the main factor which could lead to the side rail detachment/ damage might be related to an excessive force applied to the side rail.This is in line with the side rail condition.The both upper arms that are part of the side rail assembly were disconnected from the bed.The instructions for use for citadel bed (830-213-en) state to: ¿make sure the locking mechanism is securely engaged when the side rails are raised.¿ additionally, the caregiver should check operation of the side rails daily.If the result of the test is unsatisfactory, contact arjo.Based on the analysis of the complaints, the external excessive force must first compromise the integrity of the safety side prior to detachment.The arjo device failed to meet its performance specification since the side rail was detached.There is no indication that the device was used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to the side rail detachment.No injury was reported.
Event or Problem Description
The side rail was detached from the citadel bed frame.The both upper arms that are part of the side rail assembly were disconnected from the bed.There was no indication that the bed frame was in use when the issue occurred.No injury was claimed.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18370730
• Report Number: 3007420694-2023-00306
• Device Sequence Number: 7601206
• Product Code: FNL
• UDI-Device Identifier: 05056097342184
• UDI-Public: (01)05056097342184(11)190606
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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: 12/06/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2019
• 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