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

Model Number 722010

Device Problems Break (1069); Fire (1245); Fluid/Blood Leak (1250); Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

Detector chiller leaked fluid into the power strip below causing the cabinet to catch fire when the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which it was stated that they noticed that there was smoke from cabinet at turning on the system the morning.Customer used emergency shut off to turn off room.Detector chiller leaked fluid into the power strip below causing the cabinet to catch fire which self-extinguished when the power was shut off.This fire caused damage to r cabinet components and cables.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: the detector chiller leaked fluid into the power strip below causing the cabinet to catch fire, which self extinguished when power was removed.This resulted in damage to the r-cabinet and components.Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller.If this occurs the liquid may drip onto electrical components in the r-cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.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.

• 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: 6540283
• MDR Text Key: 74395140
• Report Number: 3003768277-2017-00045
• 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: 04/07/2017

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: 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
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: 04/07/2017
• Supplement Dates FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2011
• 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