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	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bed was inspected and no signs of short circuit were found, the device was functioning as intended.Since there was no malfunction of any electrical component was determined during the evaluation, the reported symptom could not be confirmed.The service technician suggest that there might be an issue with the outlet eg.Some moisture or some other factor near the outlet rather than power cable problem.Although there was no visual damage, this hypothesis could not be confirmed.The instruction for use for citadel bed (ifu, 830.213-en) includes the following information on preventive maintenance procedure regarding electrical components: ¿visually check power supply cord and mains plug.¿ this procedure has to be done weekly.If the result of this test is unsatisfactory, contact arjo or an arjo-approved service agent.Arjo device did not fail to meet its performance specification since there was no malfunction of any electrical component determined during the device evaluation.There was no allegation of patient involvement.The complaint was decided to be reportable due to allegation that power cord was sparking.
Event or Problem Description
During plug in the bed into the socket, the bed sparked.There was no indication of the patient's involvement.No injury was claimed.The arjo representative replaced the power cord, and the bed was operated as intended.No visual signs of the power cable damages was observed by the arjo representative.However, taking a conservative approach, he decided to replace the beds power cord.

• 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: 24256053
• Report Number: 3007420694-2026-00023
• Device Sequence Number: 15540211
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)200618
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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
• Operator of Device: Other
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2020
• 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: Other
• Patient Sex: Unknown