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 Cardiac Arrest (1762)

Event Date 12/13/2023

Event Type  Injury  

Event Description

It was claimed by a nurse, that a citadel plus bed frame was stuck in the trendelenburg position and the electrical bed function did not work.Allegedly, a patient using the bed went into cardiac arrest due to the bed failure.A patient was transferred from the bed to another bed.Currently, the patient is in stable condition and they have had no further issues.During pick-up of the bed frame, the error e410 was displayed on the side rail control panel, and the bed platform was stuck in the trendelenburg position.The service consultant performed a reset of the bed and all controls became functional again.

Manufacturer Narrative

The bed was picked-up and inspected.Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

During the pick-up of the bed frame, the error e410 was displayed on the side rail control panel, and the bed platform was stuck in the trendelenburg position.E410 error code is a general error, if the error e410 occurs, in the worst-case scenario it may lead to the bed electrical repositioning functions being inoperative.The service consultant performed a reset of the bed and all controls became functional again.The bed was picked up to be inspected at the arjo site.The information collected during the investigation allowed to determine that the bed frame stuck in the trendelenburg position could be related to the 2 bed frame malfunctions: hi/low actuator failure (about every 3 or 4 times during a full-function testing, the actuator that controls the hi/low and trendelenburg function had difficulty starting to move).Faulty cable located in the side rail (it caused e410 error code which was observed on the bed frame control panel).The above findings are in line with the claimed symptom, occurring e410 or actuator malfunction may cause that the bed was stuck in the trendelenburg position and did not respond to any controls.According to the available information, the citadel plus bed was used for the patient treatment at the time of the event and it played a role in the reported issue.It failed to meet its performance specification since the bed platform was stuck in the trendelenburg position.The complaint was assessed as reportable due to indication that the patient allegedly went into cardiac arrest due to the bed failure.

• 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: 18451133
• MDR Text Key: 332256776
• Report Number: 3007420694-2024-00003
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2019
• 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): Required Intervention; Life Threatening
• Patient Sex: Female