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

Model Number CX811A3F3AMAB0

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.The follow-up will be provided within next report.

Event Description

Arjo was informed about the incident with the arjo citadel bedframe involvement.The nurse reported that the left side rail of the bed was not locked when she put it up.When she went to turn the patient, she found out that the side rail was not in place and the patient fell out of the device.Following the information provided, the patient sustained a scratch on his nose.After the incident, an arjo representative visited the customer to evaluate the involved device.The service technician did not find any bed malfunction.

Manufacturer Narrative

Arjo was informed about the incident with the citadel bed frame involvement.The patient fell out of the device.The nurse stated that she raised the side rail up and when she went to turn the patient, the side rail folded down.The nurse was unsure if side rail was locked prior to moving patient.Following the information provided, as a result of the incident the patient sustained a scratch on his nose.After the event, an arjo representative visited the customer to evaluate the involved equipment.The service technician checked the operation of both right and left bed side rails and observed that the parts worked and locked properly.The technician did not find any bed malfunction that might cause or contributed to the reported event.The instructions for use for the citadel bed frame system (document number: 830.213 rev e) in the "operating instructions - side rails" section instructs the user how to raise the side rails of the bed properly: "to raise the side rail: 1.Hold either side rail handle.Pull the split side rail up and away from the bed until it locks in the raised position".The document in the "general warnings" section also warns the user: "make sure the locking mechanisms are securely engaged when the side rails are raised" and "prior to engaging any mattress turn feature, make sure that bed frame has side rails and that all side rails are fully engaged in their full upright and locked position".Additionally, in the "preventive maintenance" section of the document there is an information: "to make sure that the product continues to perform within its original specification, preventive maintenance procedure should be carried out at intervals shown: actions to be completed by caregiver daily - check operation of side rails".Based on the above information, it can be concluded that the most likely root cause of the reported incident was the use error.To sum up, the citadel bed frame was used for a patient treatment when the left side rail of the bed folded down causing the patient to fell out from the device and from that perspective the equipment did not meet its performance specifications.The complaint was deemed reportable due to the allegation that the patient fell off the bed, sustaining minor injuries.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• 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: 15100905
• MDR Text Key: 304368047
• Report Number: 3007420694-2022-00118
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)190111
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2019
• 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