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

Model Number AZURION 3 M12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 07/07/2023

Event Type  Injury  

Event Description

It was reported to philips that the azurion system¿s ¿ap¿ gets stuck and causes the physician to deviate from his standard care resulting in over exposure to the staff and patients and inaccurate treatment.It was also alleged by the physician that a patient was overexposed and had a stroke.Philips has completed a good faith effort to get further information regarding patient and procedure outcome.However, the customer has not yet provided the requested information.Philips has started an investigation of this complaint.A follow up report will be submitted if further information is received.

• 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: 17465098
• MDR Text Key: 320471696
• Report Number: 3003768277-2023-04300
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085275
• UDI-Public: 00884838085275
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AZURION 3 M12
• Device Catalogue Number: 722063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 08/04/2023
• 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