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

Model Number 722003

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up will sent to the fda.(b)(4).

Event Description

Philips received a complaint from the customer in which they stated that the x-ray images were unavailable during patient procedure.Rebooting did not help.Procedure had to be stopped.No patient harm was reported by the customer.

Manufacturer Narrative

The log files were analyzed which showed that the customer didn't receive the message 'x-ray images not available', but ¿xres not available¿.It was suggested that the mpdu (main power distribution unit) had sticky relays, causing the xres, a dedicated filter algorithm to enhance image quality for x-ray system, to not start up when the system is started and as a result, the image processor has to do overtime to take over actions from the xres.Which finally resulted in the system giving a time out and images not being available.The field service engineer was advised to replace the mpdu.The field service engineer went on site and checked the mpdu¿s, which were ok.He replaced the cmos (complementary metal¿oxide¿semiconductor) batteries on the boards and reinstalled the software on the x-res pcs.After this, the system was tested and left in working order and no recurrence of the issue has been reported.(b)(4).

Manufacturer Narrative

Final report updated after an external trigger gave new insight requiring further analysis of the complaint log files were analyzed which showed that the customer didn't receive the message 'x-ray images not available', but ¿xres not available¿ the field service engineer (fse) has been unable to determine the cause of the problem.The system was operational on arrival.The field service engineer checked the mains power distribution unit¿s, which were working properly.He replaced the cmos (complementary metal¿oxide¿semiconductor) batteries on the boards and reinstalled the software on the x-res pcs.The disappearance of the image as reported by the customer can not be caused by the failure of the x-res function, because the standard algorithm is performed in this case.Our specialist has analyzed the log files, but no conclusion can be drawn regarding the cause of the timeout.The actions performed on site by the fse were not related to the error as observed.The problem has not happened again since (b)(6) 2016.Philips has checked all service work orders from this system.We see no other opportunities to further investigate this event because the actual cause could never be verified.The system operates after the event as expected.

• 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: 5570459
• MDR Text Key: 42995387
• Report Number: 3003768277-2016-00038
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2009
• 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