MAUDE Adverse Event Report: Arjohuntleigh Polska Sp. z o.o. CITADEL PLUS; Bed, Ac-Powered Adjustable Hospital

Model Number	FX811B3B4AMABB
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Apnea (1720); Low Blood Pressure/ Hypotension (1914); Dysphasia (2195)
Date of Event	07/14/2026
Type of Reportable Event	Death
Event or Problem Description
Based on the collected information, a patient on comfort care, was experiencing difficulty breathing, and low blood pressure after caregivers rolled the patient to change the bed sheets.Caregivers positioned the citadel plus bed in reverse trendelenburg to boost the patient's breathing.After doing so, the bed made a loud noise and then all the lights started to blink.The bed remained locked in reverse trendelenburg.According to the information provided, the patient became apneic, and pulseless, and subsequently passed away.At this time, no additional clinical details have been provided regarding the cause of death.There was no allegation that the bed caused or contributed to the patient's death.The bed was inspected by arjo service technician.No malfunction was found.

• Brand Name: CITADEL PLUS
• 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
• MDR Report Key: 50218916
• Report Number: 50218916
• Device Sequence Number: 10255628
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)201028
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026
• Report Date (Section F): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/14/2026
• Date Report to Manufacturer: 08/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 349 LB
• Date Report Sent to FDA: 08/12/2026