MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10/10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722011

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which was stated that the coolant for the flat panel detector leaked on a power terminal block in the cabinet.This caused the smoke alarm to alert in the equipment room.No patient or user harm was reported by the customer.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: a philips field service engineer, confirmed the problem.There was short circuit damage to the terminal strip of the r-cabinet (x400 terminal strip and green 220v outlet), caused by a failure of the chiller hose clamp.The drip pan worked to catch most of the fluid, but some cooling liquid dripped beyond the drip pan range on the terminal strip.This has resulted in a short circuit.Philips initiated a field safety corrective action (b)(4) 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 FD10/10
• 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: 6275554
• MDR Text Key: 65946135
• Report Number: 3003768277-2017-00007
• 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: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722011
• Device Catalogue Number: 722011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2010
• 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