MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20 BIPLANE (FD20/15); ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER

Model Number 722058

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.(b)(4).

Event Description

Philips received a complaint from the customer in which they stated that they started a procedure for treatment on a patient with an aneurysm, during the treatment the system stopped working.The system was restarted several times, finally they were able to finish the procedure.This restarting caused a delay in the treatment of the patient.After the treatment the patient had no feeling in left hand and left foot.Geometry movements were partially unavailable and the image on the screen turned purple, system was not generating x ray.

Manufacturer Narrative

Philips investigated the complaint and came to the following conclusion: investigation of the logfiles and information of the philips field service engineer showed that following series of events occurred: the frontal live image on the flexvision screen (left image) went black at 53 minutes after start of procedure.To restore the quality of the image to expected level the system was restarted (warm restart) after 55 minutes after the start of the procedure.The restart was completed at 14:57 minutes.This did not result in full recovery of the image quality: the image appeared on the screen, with a purple background.In a second attempt, to improve the image quality, the operating physician initiated a ¿cold restart¿ of the system.After this ¿cold restart¿ the quality of both images, left and right was restored to expected level.This ¿cold¿ or complete restart of the system however had triggered a limitation in the geometry movement.When a movement or current is measured during startup, the stand will not be powered on, because of safety risks.Another cold restart was necessary to regain full recovery of both the image and the geometry function.The procedure was continued after 1 hour and 29 minutes (after start of the procedure) and the stent was placed successfully.After 4 hours and 49 minutes the stent placement was successfully terminated.The first issue (the ¿black screen¿) was identified from the log files (at 14.54 ¿signal lost on channel 0¿) to be located in the connection between the ip pc frontal image and the frontal live or left image on the display of the monitor.Since it could not be reproduced and the cause cannot be identified from the log files, so therefore we cannot determine the cause for the lost connection.The following contributing factors (probable root causes) were identified: a rare issue with the flexvision monitor (not reproducible electronic signal transmission error): the black screen issue could be due to a connection problem between the ip pc frontal image and left image on the display of the monitor.No errors related to purple screen were detected in the logfiles.Because the issues could not be reproduced by the fse, this is characterized as a single event.Both issues were ¿one- offs¿¿, no similar issues were found during investigation, and the combination is certainly the first one to be reported.The cold restart in combination with not cooling down of the system caused the i/speed zero error resulting in a limitation in the geometry movement in section 3.2.3.Of the instructions for use the following is mentioned: ¿do not switch the system power off immediately after the system has been used.The x-ray tube should be allowed to cool down for several minutes, especially after heavy usage¿.

• Brand Name: ALLURA XPER FD20 BIPLANE (FD20/15)
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER
• 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: 5955580
• MDR Text Key: 54892153
• Report Number: 3003768277-2016-00084
• Device Sequence Number: 1
• Product Code: OBW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722058
• Device Catalogue Number: 722058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2014
• 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
• Patient Outcome(s): Other