MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PATIENT CARE SYSTEM; BED, FLOTATION THERAPY, POWERED

Model Number CX811A3F3AMAB0

Device Problems Misassembled (1398); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

Following the information provided the patient attempted to exit the bed and fell on his right side.After the fall the patient complained of injuries to right shoulder and hip and therefore was transported for diagnostics to receive x-ray and ct scan.It was confirmed that no injury was sustained as a result of the fall.The bed did not have a nurse call communication cable connected to hospital system at that time.The evaluation of the bed did not reveal any damages or malfunctions.

Manufacturer Narrative

The investigation is in progress.Conclusions willl be provided within the follow-up report once the investigation is completed.

Event Description

Following the information provided the patient exited the bed and fell on his right side.The patient allegedly complained of injuries to right side, shoulder and hip but x-rays and ct scan did not show any harms.The nurse call cable, which is connected to the customer¿s internal call system, was not installed to the bed frame and the bed egress alarm allegedly did not sound when the patient left the bed.The alarm detects patient¿s movements, however it will not restrain patient from leaving the bed.An arjo service technician assessed that there were no visible signs of damage to the bed and installed a nurse call cable.The bed worked as intended upon inspection.

Manufacturer Narrative

Based on the collected information and device evaluation results it is most likely that the bed exit alarm worked as intended, however it could not be heard in the nurses' room, because the bed was not connected to the hospital nurse call system due to missing nurse call cable.The reasons for which the patient left the bed are not known, however based on the information that the patient first exited the bed and then fell, it is concluded that the attempt to leave the bed was deliberate.As per the hospital policy, each bed that arjo delivers needs to have a nurse call cable included.Arjo representative confirmed that the nurse call cables are tied to the bed upon delivery.This bed was in use with the patient for 28 days before the incident without any report of deficiencies.It is most likely that the cable was not connected to the hospital system after the patient transfer to another ward, which took place 2 days before the incident.The instructions for use (ifu) for citadel bed frame system (830.213-en) includes the following information related to the investigated event: "verify correct operation of the nurse call system before placing a patient on the bed".Arjo device failed to meet its performance specification since the nurse call cable was missing.The device was used for a patient treatment when the event occurred.The complaint was assessed as reportable due to allegation about patient's fall.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: 15417527
• MDR Text Key: 306191993
• Report Number: 3007420694-2022-00149
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)200624
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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: Lay User/Patient
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• 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