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

Model Number AZURION 7 M20

Device Problem Unintended System Motion (1430)

Patient Problem Pneumothorax (2012)

Event Date 09/07/2023

Event Type  Injury  

Event Description

It was reported to philips that when preparing for a cone-beam computed tomography (cbct), the technologist selected the cbct function and then accidentally pressed the ¿reset geo¿ button instead of the ¿accept¿ button.Pressing the ¿reset geo¿ button reset the device¿s stand and table position which made the table raise and move laterally, causing an endotracheal (et) tube and catheter to move within the patient¿s lung.The patient was diagnosed with a pneumothorax at the end of the case, which required a chest tube be placed and the patient stay overnight in the hospital.The physician stated they believed the movement of the table could have caused the pneumothorax.The patient¿s status was reported as recovered.Philips has started an investigation of this complaint.

• 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: 17994297
• MDR Text Key: 326355401
• Report Number: 3003768277-2023-05775
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M20
• Device Catalogue Number: 722224
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2023
• Date Device Manufactured: 02/01/2021
• 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