MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number AZURION 7 M20

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported to philips that the azurion system images were grainy and the error message "low load fluoro, tube cooler problem¿ was displaying during the procedure.Rebooting did not resolve the issue and the procedure was aborted.The device was in clinical use at the time of the event.No harm to the patient or user was reported.A philips field service engineer (fse) inspected the system onsite and changed mains resistance from 180mohm to 72mohm per cat tool recommendation and recalibrated the generator.The device was returned to use in good working order.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected a planned treatment was performed when this happened.The procedure was aborted, and it completed by moving the patient to another room.The philips field service engineer (fse) analyzed the system onsite and confirmed that system images were grainy and the error message during the procedure.After reviewing the log file fse confirmed that most likely cause is in x-ray generator hardware and the flow switch of clm is defect.Fse changed mains resistance.After repairs were completed, the system was returned to use in good working order.

• Brand Name: AZURION
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17988040
• MDR Text Key: 326306705
• Report Number: 3003768277-2023-05757
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838099258
• UDI-Public: 00884838099258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M20
• Device Catalogue Number: 722224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• 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