MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PATIENT CARE SYSTEM; BED, FLOTATION THERAPY, POWERED

Model Number	CX611B3F4AMAB0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was claimed by customer that the mattress was not filling in the center and the patient's pressure sore worsened.The patient sustained a serious injury (left hip buttocks injury) the device was swapped out.During the evaluation was found that the airbox malfunctioned.The compressor leakage was identified.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• Common Device Name: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 21393328
• Report Number: 1419652-2025-00009
• Device Sequence Number: 8746607
• Product Code: IOQ
• UDI-Device Identifier: 05056097342184
• UDI-Public: (01)05056097342184(11)190918
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/18/2025
• Report Date (Section F): 02/18/2025

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
• Operator of Device: Other
• Device Model Number: CX611B3F4AMAB0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/21/2025
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 02/18/2025