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

Model Number AZURION 7 M20

Device Problem Communication or Transmission Problem (2896)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

It was reported to philips that after importing a patient from a worklist and exporting the patient's images from the azurion to the picture archiving and communication system (pacs), the images were mixed between different patients.The system was in clinical use.Additional information received from the philips field service engineer (fse) indicated no injury occurred and that the mixed images were detected by the physician's staff.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the issue occurred during a coronary treatment and the procedure was completed as planned.No patient harm was reported.The philips field service engineer (fse) inspected the system onsite and found that the images were mixed between the patients.The customer tried to import the patient data on the system from the worklist and pressed fluoro pedal before selecting start procedure.Due to this, the system changed accession number (unique patient identifier) for another accession number of another patient present on the worklist.Hence, the images were mixed with another patient data.The fse instructed the customer to press start procedure first before pressing fluoro pedal, in order to avoid the software bug and image mix issue.After the repair, 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18137832
• MDR Text Key: 328110081
• Report Number: 3003768277-2023-06266
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085268
• UDI-Public: 00884838085268
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K172822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 11/15/2023
• 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: 722079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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