MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL BED FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	CX611B3F4AMAB0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/25/2024
Type of Reportable Event	Death
Event or Problem Description
It was claimed by a customer that the patient fell while trying to grab the safety side.The nurse was cleaning the patient and when she rolled the patient to the other side, the patient rolled off the bed.Allegedly the safety side was not working as correctly and it fell when the patient was trying to reach it.The patient coded and expired within minutes from the incident.The arjo field service engineer inspected the device on-site and found no issue with the bed.All safety side were functioning as intended.It was found only the footboard missing.
Additional Manufacturer Narrative
The investigation is ongoing.

• 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: 20516982
• Report Number: 1419652-2024-00063
• Device Sequence Number: 20803386
• Product Code: FNL
• UDI-Device Identifier: 05056097342184
• UDI-Public: (01)05056097342184(11)200730
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/23/2024
• Report Date (Section F): 10/23/2024

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: 09/25/2024
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2024
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/23/2024