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

Model Number FX811B3B4AMABB

Device Problem Activation Problem (4042)

Patient Problem Respiratory Failure (2484)

Event Date 01/19/2024

Event Type  Death  

Manufacturer Narrative

Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

It was claimed that the patient went into respiratory distress at the time of use of the citadel plus bed frame.The facility staff tried to lower the backrest section of the bed to provide resuscitation but the electrical cardiopulmonary resuscitation function (cpr) did not work.Allegedly, the error code was displayed on the side rail control panel at that time.The patient¿s condition deteriorated.The patient passed away two days after this event.The customer¿s allegation about the malfunction of electric cpr and occurring of the error code on the side rail control panel was not confirmed during the bed frame comprehensive evaluation conducted by the arjo representatives.The bed passed all tests, all cprs worked, no error codes were displayed on the side rail.

Manufacturer Narrative

Customer stated that the electrical cardiopulmonary resuscitation function (cpr) was not responding when the bed was stuck during the patient's respiratory distress.The patient subsequently died.During the investigation and review all collected information, it was established that on the day of the incident, the customer informed that the bed was stuck in the trendeleburg position, they could not straighten the bed (to straighten the bed the user needs to press button located on the side rail control panel).The caller also stated that some functions worked and allowed to receive the fowler (sitting) and semi-fowler position.Two days later, the another person from the facility referred that the customer staff ¿could not lower the head or bed down¿ to provide resuscitation.We are not able to confirm the customer¿s allegation.The bed was evaluated by the arjo service technician who did not identify any fault.The bed moved as expected, it did not stuck in trendelenburg, both cpr ¿ electrical and manual were working properly, no error codes were displayed on the control panel.In case of electric cpr failure and lack of the bed electrical functions (as reported in this case), the citadel plus is equipped with a manual cpr backrest release handle which will lower the backrest to enable cardiopulmonary resuscitation.The customer staff did not use manual cpr because they did not know how it works.In panic, they do not remember what the staff did and what did not.The patient expired on 22 jan.Initially, the customer staff stated that they did not believe the bed contributed to the patient death, sue to other complications (stating covid as one).Later the customer said that ¿the bed probably contributed to the death as the patient turned purple and they tried to keep the patient up using blankets and pillows, but since the patient was 250kg it was hard to keep him up.¿ according to the information received from the customer, the citadel plus bed was in use and it played a role in the reported event since the bed's functions were not operating.However, the customer allegation was not confirmed during the bed evaluation, the bed operated correctly.The root cause of the claimed event could not be determined.The complaint was decided to be reportable due to the allegation that the electrical cpr was not working during the patient's respiratory distress.

• 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: 18675288
• MDR Text Key: 335005801
• Report Number: 3007420694-2024-00044
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2019
• 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): Death; Life Threatening; Required Intervention
• Patient Sex: Male
• Patient Weight: 250 KG