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

Model Number 722010

Device Problems Fire (1245); Smoking (1585); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Philips was informed by the customer that on (b)(6) at 7:15 am they started up the room.The philips live and data monitors started and were working but none of the other electro physiologic cockpit monitors were working.The customer shut the room off and turned it back on.None of the monitors worked then.The customer then went to the equipment room to make sure that the system had turned on and that is when they discovered that the equipment room was full of smoke.There was then a code red called and the fire department arrived and extinguished the fire.No patient or user was harmed due to this issue.

Manufacturer Narrative

The fire investigation provided a clear indication of the physical location where the fire started, namely at the power rail at the back of the r-cabinet.As a result, the most likely root cause is leakage of cooling liquid on the power rail.Tests in the quality lab have confirmed that leakage of cooling liquid on the power sockets can lead to tracking and the start of a fire.Philips inspected 20 systems in the field.For each of these systems, a cooling liquid leak had been reported in the past.In these systems, we have seen the events that make up this root cause.We have seen residues of cooling liquid on the power rail and also tracking (break down of the insulator) in one components on the power rail.Philips investigated this complaint and came to the following conclusion: due to a leak in the detector cooling system, cooling liquid leaked outside the drip tray of the chiller.The liquid dripped onto electrical components in the r-cabinet located in the technical room, which lead to damage of the system and caused this thermal event.Philips initiated a field safety corrective action fco 72200384 which is targeted towards root cause cooling fluid leaking onto the connector.This field safety corrective action was filed to the fda on 2017mar22.Z-1820-2017, z-1821-2017.

• 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: 5808120
• MDR Text Key: 50911731
• Report Number: 3003768277-2016-00069
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2016
• 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
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1820-2017, Z-1821-2017
• Patient Sequence Number: 1