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	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Following the information gathered, the bed platform lowered without activation any buttons on control panel.The event was observed in arjo service center.The technician during quality check found stucked control panel button.The safety side was replaced and the bed started to operate correctly.No allegation from the customer site was claimed.There was no patient involvement.No injury was claimed.
Additional Manufacturer Narrative
The investigation is on-going.Further information will be available in the next expected report.
Additional Manufacturer Narrative
The data are still analysed.Once investigation is completed a follow-up report will be provided.
Additional Manufacturer Narrative
The data are still analysed.Once investigation is completed a follow-up report will be provided.
Additional Manufacturer Narrative
The data are still analysed.Once investigation is completed a follow-up report will be provided.
Additional Manufacturer Narrative
It was claimed that the bed platform lowered without activation of any buttons on the control panel and would not come back up.The situation occurred in the arjo service center while performing the bed evaluation.There was no allegation from the customer site.There was no patient involvement.No injury was claimed.The quality control technician noticed that the foot side rail was damaged (dent in the plastic panel) and the button stuck on the control panel.The safety side was replaced and the bed started to operate correctly.The instruction for use for citadel bed (830.213-en rev.12) informs that patient controls, caregiver controls and attendant control panels should be checked weekly.The review of complaints and device inspection results indicate that the control panel button failure (stuck button) found during inspection might have led to the observed unexpected bed movement.The main factor that could lead to the button being stuck might be related to an excessive force applied to the control panel (originating from collisions with objects, such as door frames or from the bed being pressed against a different surface, such as a wall).This is consistent with the side rail condition that has bent in the plastic panel.In summary, the device was not used with the patient when the failure was noticed.The bed failed to meet its specification since the bed lowered unintended.This complaint is deemed reportable due to the unintended movement.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: 19190059
• Report Number: 3007420694-2024-00116
• Device Sequence Number: 7640359
• Product Code: FNL
• UDI-Device Identifier: 05056097342184
• UDI-Public: (01)05056097342184(11)190827
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/24/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/21/2024; 07/19/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2019
• 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