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

Model Number AZURION 7 M12

Device Problem Poor Quality Image (1408)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the image was degraded.The issue was found during clinical use and the procedure could not be continued.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips remote service personnel and has been investigated that images were degraded during the examination.The issue was occur during clinical use and the procedure could not be continued.Rse suggest multiple attempts were made to obtain the device evaluation, repair, and operational status with no approval from the customer.No further information was provided.The system was returned to use in good working order.The codes were updated based on the investigation outcome.

• 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: 17841086
• MDR Text Key: 324553754
• Report Number: 3003768277-2023-05383
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838099241
• UDI-Public: 00884838099241
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K200917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M12
• Device Catalogue Number: 722223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2022
• 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