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

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon investigation cocnlusion.

Event Description

It was reported that a patient migrate toward the foot of a citadel and fell to the floor.The customer confirmed there was no device malfunction noticed.A patien wast hallucinating and migrated to foot of the bed and to the floor.They most likely cargiver didn¿t have safety settings engaged.

Manufacturer Narrative

Following the information provided, the patient migrated toward the citadel bed foot section and fell to the floor.There was an injury sustained by the patient, but the information about the outcome remains unknown due to lack of details provided by the customer.Additionally, the customer stated that the patient was hallucinating at that time.According to the information provided, the patient passed away after the incident.The customer stated that the patient died from other complications.No further details were provided.The device was not available for the inspection, but the customer stated that there was no failure within the bed.The arjo service technician suspected that most likely there were no safety settings engaged.The nurse call system was not working with any assets at the facility.Additionally, the customer¿s representative stated that using side rails is considered as a form of restraint.The instructions for use for citadel (830.213 en) includes consideration regarding usage of side rails: - "whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail/restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and/or family.Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed (.).It is recommended that side rails (if used) be locked in the full upright position when the patient is unattended." based on the information obtained during this investigation, it might be concluded that the patient's fall could be related to the patient hallucination.The side rails might not have been placed in a raised position, however even if the side rails would be raised, it is unknown, if they could prevent the fall, especially when considering the patient's condition at the time of the event.To sum up, there was no indication of any malfunction on the claimed device.The device was used for a patient treatment when the event occurred and therefore was involved in the event, however it did not fail its specification.This complaint is deemed reportable due to patient's fall from the bed.H3 other text: not available.

• 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: 16395224
• MDR Text Key: 309854064
• Report Number: 3007420694-2023-00034
• Device Sequence Number: 1
• Product Code: FNL
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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