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	Failure to Run on Battery (1466)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Respiratory Arrest (4461)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient experienced a seizure, followed by respiratory arrest and the citadel bed did not perform as intended for a code blue.It was stated the battery died and the patient had an emergency intubation and was transferred to icu.According to the arjo clinical specilist the patient's intubation and transfer to icu does meet the definition of a serious injury.Additionally, as a result of this event, the caregiver had to support the patient's position to maintain the patient's airway, which caused the caregiver to injure their back.However, there was no indication that the caregiver's back injury was serious.
Additional Manufacturer Narrative
The investigation is ongoing.Results will be provided in the final report.

• 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
• MDR Report Key: 50065929
• Report Number: 50065929
• Device Sequence Number: 18693622
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)201020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 07/29/2026
• Report Date (Section F): 07/29/2026

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: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/02/2026
• Date Report to Manufacturer: 07/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/29/2026