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

Model Number FX811B3B4AMABB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 02/11/2023

Event Type  malfunction  

Manufacturer Narrative

Arjo became aware of an event involving a citadel plus bed frame.The customer staff claimed, that the patient fell from the bed due to a side rail detachment.Allegedly, the patient was trying to exit the bed at that time.No injury was reported.The review of post-market surveillance data and the investigation carried out at the manufacturer site revealed that the main factor which could lead to the side rail mechanical damage might be related to an excessive force applied to the side rail.This is in line with the side rail condition (it was mechanically damaged) and circumstances of the event.The arjo technician who inspected the bed frame assessed that the side rail detached because it was kicked by the patient.The nurse informed that the patient was very disoriented.The patient believed it to be the year 1923 (per the patient¿s nurse).According to the citadel plus instruction for use (831.374.En): ¿the clinically qualified person responsible should consider the age, size and condition of the patient before allowing the use of side rails.¿ ¿side rails are not intended to restrain patients who make a deliberate attempt to exit the bed.¿ based on the analysis of the complaints, the external excessive force must first compromise the integrity of the safety side prior to breaking it.The side rail was detached and from that perspective, the citadel plus bed did not meet the performance specification.The device was in use when the side rail was damaged.No injury was reported.The complaint was decided to be reportable due to the patient fall caused by the side rail panel detachment.

Event Description

Arjo became aware of an event involving a citadel plus bed frame.The customer staff claimed, that the patient fell from the bed due to a side rail detachment.Allegedly, the patient was trying to exit the bed at that time.No injury was reported.

• Brand Name: CITADEL PLUS
• Type of Device: 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: 16458114
• MDR Text Key: 310417255
• Report Number: 3007420694-2023-00043
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)201021
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 181 KG