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

Model Number AZURION 7 B20

Device Problems No Display/Image (1183); No Apparent Adverse Event (3189)

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

Event Date 04/14/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the images were grey.No harm has been reported to philips.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was not in clinical use while the issue was reported.A philips service engineer inspected the system remotely and determined that customer only want to create a fluoro on hi setting, there was no malfunction was reported.Engineer provided the information to customer on how to build a specific protocol for neuro device.The system meets the specification for the performed service and was returned to use.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which has led to the determination that this is scenario is not likely to cause or contribute to death or serious injury if it were to recur.There was no reported product malfunction in this case.The customer had requested information regarding how to create a fluoro on hi setting.Philips has re-evaluated this case as not reportable.The codes were updated based on the investigation outcome.Health impact code and device problem code were 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: 16813589
• MDR Text Key: 313988856
• Report Number: 3003768277-2023-02516
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838099272
• UDI-Public: 00884838099272
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 B20
• Device Catalogue Number: 722226
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2023
• 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