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

Model Number 722003

Device Problems Fire (1245); Device Emits Odor (1425); Smoking (1585)

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 received a complaint in which the customer stated that they noticed a burning smell during start up of the system, smoke was coming from equipment room.The sprinkler system came on, in the equipment room.Equipment room and exam room flooded.The system was not in clinical use, no patient or user was harmed due to this fire.

Manufacturer Narrative

Verified r-cabinet was source of short circuit/fire damage.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: 5938800
• MDR Text Key: 54280331
• Report Number: 3003768277-2016-00082
• 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: 08/22/2016

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: 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
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2010
• 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