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

Model Number 722026

Device Problem Computer Operating System Problem (2898)

Patient Problem Death (1802)

Event Date 07/01/2015

Event Type  Death  

Manufacturer Narrative

When investigation is completed a follow up report will be sent to fda.(b)(4).

Event Description

Philips received a complaint from a customer that during an emergency procedure for a temporary pacemaker implantation, the system needed a reboot.This caused a delay in the treatment and the patient died.

Manufacturer Narrative

Philips investigated this complaint and found that the issue is caused by a communication problem between the software (acontis datalink driver vxworks) and the hardware (intel 82573l gigabit ethernet controller) of the geometry industrial pc.This causes a power on self test error of the geometry, and as a consequence geometry movements and positions not being available.The observation that the images are rotated 90 degrees is correct, because of the absence of the geometry positions the image cannot be corrected for the geometry orientation.The customer did not allege that the death of the patient was caused by the philips cathlab a solution for this issue is available and will be implemented.(b)(4).

• 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 Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 5009843
• MDR Text Key: 23233374
• Report Number: 3003768277-2015-00068
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 07/22/2015

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: 722026
• Device Catalogue Number: 722026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death