MAUDE Adverse Event Report: PHILIPS HEALTHCARE AZURION 7 B20; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 722068

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing for this event.When the investigation is completed a follow up will be sent to the fda.

Event Description

It has been reported to philips that the xper ct images had an artefact in the head base.During a thrombectomy to remove a clot in the brain artery, the patient developed a bleeding.The customer was not able to see the bleeding on the xper ct images.The procedure was completed successfully using normal ct.

Manufacturer Narrative

Philips has investigated this complaint.Initially it was reported that the customer could not see the bleeding on the xperct image and used normal ct to complete the procedure.During the investigation, philips has confirmed that the physician was able to see the bleeding on the xperct images and the procedure was completed using the xperct.There was no delay in the procedure.No harm to the patient was reported.As described in the instructions for use (12nc: 452220373732xperct dual r3.4), a diagnosis cannot be solely based on the artificially generated images via the xperct tool.All the findings, decisions and diagnoses must be confirmed by using conventional (2d) x-ray imaging.Philips has inspected the system on site and confirmed that the system is working according to specification.Log file analyses confirmed that due to a software implementation error, when the last channel used for x-ray is the lateral channel and then the 3d protocol for xperct, this issue occurs.The issue does not occur when the frontal channel is selected and then the 3d protocol for xperct is selected.Based on the investigation, philips has confirmed that this malfunction is due to a software implementation error in versions of azurion 1.2 and 1.2.1.This issue will be fixed in the next software implementation.Philips has inspected the system on site and confirmed that the system is otherwise working according to specification.No similar complaints have been identified.Consequently, philips has closed this complaint.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: AZURION 7 B20
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 9731944
• MDR Text Key: 183889364
• Report Number: 3003768277-2020-00012
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085367
• UDI-Public: (01)00884838085367
• Combination Product (y/n): N
• PMA/PMN Number: K172822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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: 722068
• Device Catalogue Number: 722068
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 80