MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722010

Device Problem Poor Quality Image (1408)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 09/25/2017

Event Type  Death  

Manufacturer Narrative

According to the information we received the system was not able to store images as the memory was full.When the investigation has been completed, philips will inform the fda.

Event Description

Philips has been reported that during an interventional procedure to place 3 stents, stent positioning was only possible using fluoroscopy, resulting that image quality was not ideal due to the fact that there was no possibility to document and to record the image which would have meant better image quality.A doctor at the hospital indicated that patient could not be treated adequately.Patient was being treated due to an acute heart attack.After finishing the procedure the patient was transferred to the intensive care and died.According to a nurse of the hospital, patient died due to his bad condition.

Manufacturer Narrative

A philips service engineer checked the system on site and confirmed that the image disk was full.Because the image storage was full, no more/runs could be generated.Analysis of the log file showed that the procedure was done using the low fluoro flavor which is a default setting.For a better image during the procedure, medium or normal flavor for a higher dose could have been used instead as they were also available.The system prompted warning messages on the lack of space as confirmed in the system log file.Investigation showed that the third party pacs connected to the allura system was not providing the confirmation of reception of the images transferred and therefore the images were being stored in the allura system instead of automatically being deleted the images once the transfer to the pacs was completed.This resulted in the image disk being full.The issue was solved by a field service engineer of the third party pacs product by changing the settings in the pacs.Philips provided training on how to manage disk space.No reoccurrence of the issue has been reported to philips.

Manufacturer Narrative

A philips service engineer checked the system on site and confirmed that the image disk was full.Because the image storage was full, no more/runs could be generated.Analysis of the log file showed that the procedure was done using the low fluoro flavor which is a default setting.For a better image during the procedure, medium or normal flavor for a higher dose could have been used instead as they were also available.The system prompted warning messages on the lack of space as confirmed in the system log file.The cause for this problem was the transfer of the modality performed procedure steps-data (mpps-data) to the (b)(4)-system/server.The receiving service on (b)(4) server was not working anymore, therefore the images continued being stored in the allura system.This resulted in the image disk of the allura system became full.This issue was solved by a field service engineer of (b)(4) by changing the settings in (b)(4)-system/server.Philips provided training on how to manage disk space.No reoccurrence of the issue has been reported to philips.

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 6917012
• MDR Text Key: 88366839
• Report Number: 3003768277-2017-00083
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 722010
• Device Catalogue Number: 722010
• Other Device ID Number: HEMODYNAMIC SYSTEM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 09/25/2017; 09/25/2017
• Supplement Dates FDA Received: 01/19/2018; 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• 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