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

Model Number AZURION 3 M15

Device Problem No Display/Image (1183)

Patient Problems Ventricular Fibrillation (2130); Insufficient Information (4580)

Event Date 04/25/2023

Event Type  Death  

Event Description

It has been reported to philips that during a planned cardiac angiography procedure for a patient with blocked coronary arteries, the monitors in the exam room went black and a white line appeared in the middle.The system was frozen and exposure was not possible.The user restarted the system and after 10 minutes, x-ray functionality resumed.The customer reported that the patient passed away on the table.Philips has started an investigation of this complaint.

Manufacturer Narrative

Addtl narrative: philips has investigated the reported incident.According to the information received, on (b)(6) 2023, a stent was placed for which pre-dilation could not be completed as the viewing area on the monitors allegedly went black and a white line appeared in the middle of the image.The patient underwent ventricular fibrillation and cpr was initiated.Philips has concluded, with the evidence available in the log files and the investigation of the incident, that the shutter closure, table movement, and restart were all valid commands initiated by the user.The system was behaving normally, with no evidence of the alleged freeze.Philips will further comment on the events that occurred below.With regards to the reported ¿white line¿, after the incident, a technical investigation of the log files was conducted.This indicated that at the time of the event, the table was removed from the field of view of the detector, multiple table force sensor collision detections had occurred, and the table height was lowered.These errors occur when physical force is applied to the table, suggesting that at the time of the event the table was being subject to force consistent with cpr.After the table force sensor collision detection, the log file identified that the joystick on the control module in the examination room registered a shutters closure command.The shutters were closed inwards, which takes approximately four seconds, to reach the minimum allowable 2 millimeters of open space between them.This command, however, was maintained for an additional 58 seconds after the shutters had already fully closed.This is indicative of unintended activation of the control module by user interaction.The log files also showed that the table was then moved back into the field of view of the detector and multiple attempts were made to initiate fluoroscopy and exposure with closed shutters.Any imaging taken with closed shutters would display a horizontal line, as the shutters would only allow radiation through the 2 millimeter gap.This matches the ¿white line¿ description from the customer¿s report.Philips¿ fse confirmed that no malfunction of the system was identified related to the shutter closure or the collimator, because the commands to close the shutter were initiated by user interaction.With regards to the reported ¿system being frozen and exposure not being possible¿, the restart completed in 273 seconds which is within the specifications that a cold restart should not exceed 360 seconds.During the restart, several fluoroscopy attempts were made which were unsuccessful due to the generator not having completed it¿s start-up sequence, which is normal behavior.Philips has established that prior to this event, on 4 april 2023, a philips fse visited the site and identified that the system¿s small focus tube was broken and required replacement.This device has two focus ranges; small and large, which is designed for graceful degradation [1] to allow the continuation of use in the event of a focus tube failure.The customer was made aware the system did not meet all technical specifications and was available for limited use only but elected to not have the tube replaced at that time.After this event, the fse replaced the small focus tube and returned the device to full clinical use in good working order.[1] graceful degradation is a design principle that ensures that the functionality of a computer, machine, electronic system, or network can be maintained (albeit to a limited extent) if a large part of the system is destroyed or rendered inoperable.The purpose is to prevent complete system failure.Codes are updated based on the investigation outcome.----------------- corrected data: patient outcome code was corrected.

• 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: 16874853
• MDR Text Key: 314612410
• Report Number: 3003768277-2023-02707
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085282
• UDI-Public: 00884838085282
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K172822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AZURION 3 M15
• Device Catalogue Number: 722064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2019
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 70 KG