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

Model Number FX811B3B3AMABB

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

The circumstances in which the patient fell from the bed are unknown.It is also unknown if the side rail were used at time of the event.The arjo service consultant was only able to establish that the rotation function was not turn on the mattress at that time.At time pick-up of the bed frame, the e410 error code was displayed on the side rail that could not be cleared by the arjo service consultant.The further device inspection revealed that the error code occurred due to the side rail internal cable malfunction.If the error e410 occurs, in the worst case scenario it may lead to the bed electrical repositioning functions being inoperative.No relation between the detected malfunction and the patient fall was found.This conclusion is in line with the customer¿s statement, there was no allegation from the nurse that the device had any malfunction that caused the patient¿s fall.Based on the collected information, the root cause of the claimed event could not be determined.According to the citadel plus instruction for use, 831.374 rev.I: ¿to minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended.¿ ¿whether and how to use side rails or restraints is a decision that should be based on each patients needs and should be made by the patient and the patients family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail / restraint use.¿ sum up, arjo device was used for the patient treatment when the event occurred and played a role in the event.The error code was displayed on the side rail, therefore, the citadel plus bed did not meet the performance specification.No relation between the detected malfunction and the patient fall was found.The complaint decided to be reportable due to the patient¿s fall.No injury was claimed.

Event Description

It was claimed by a nurse that a patient fell from a citadel plus bed frame.There was no allegation from the nurse that the device had any malfunction that caused the patient¿s fall.No injury was claimed.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18326136
• MDR Text Key: 330495182
• Report Number: 3007420694-2023-00297
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)200622
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/14/2023

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
• Device Operator: Health Professional
• Device Model Number: FX811B3B3AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2020
• 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