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

Model Number 722010

Device Problem No Display/Image (1183)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining more detailed information.When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which it was stated that at the moment an emergency patient (treated with a chest compressor for cpr) was put on the patient table the left side of the flexvision monitor went black.The customer decided to move the patient to another room to proceed with the treatment.No information about the patient was received by philips.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: the issue happened on (b)(6)2017 and there are no logfiles available of this event.On (b)(6)2017, the system is upgraded towards a 8.1.25 system, replacing a lot of hardware which could be involved in the issue.After the upgrade, the issue did not occur anymore.Philips became aware of the issue on (b)(4)2017, so after the system was already upgraded and the log files were lost.Because the system is upgraded, we cannot investigate this issue anymore.Furthermore our expert stated as long as the flexvision pc and the touch screen module (tsm) are operational, the layout of the images as presented at the large screen can be changed (by the doctor) in order to have the live xray image being shown at the other half of the screen.

Manufacturer Narrative

There appeared to be an error in the final report (b)(4) (mdv/mdr) sent yesterday.In the reports is mentioned a become aware date of (b)(6) 2017.In the manufacturer analysis result was mentioned a different become aware date.This date has now been corrected to (b)(6) 2017.

• 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: 6424610
• MDR Text Key: 70874668
• Report Number: 3003768277-2017-00035
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 03/16/2017

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: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: 03/16/2017; 03/16/2017
• Supplement Dates FDA Received: 07/05/2017; 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2010
• 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