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
In relation to battery, the product instruction for use (ifu 830.213 rev.15) states: "battery indicator- indicates status of the battery system." "caution- to make sure the battery is kept fully charged and prevent damage to the battery, the bed should be connected to the electricity supply at all times during normal use." "caution- the battery is intended for emergency short-term use only.Its life will be reduced if it is used to power the bed for long periods." "the backup battery allows operation of the bed for short periods when it is unplugged or in emergency situations when the electricity supply is not available." "if the acp battery indicator led lights red, the battery is less than 10% charged.In this condition, all functions are locked.Plug bed in." the process of analysisng data is ongoing to establish the root cause of the event.
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
• 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 ; +48()883337089
• MDR Report Key: 50065932
• Report Number: 3007420694-2026-00123
• Device Sequence Number: 18693623
• 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: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/28/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female