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

Model Number 722010

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

The generator converter failed during use of the system.When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint where it was reported to philips that: during a procedure the user noticed smoke and small orange sparks inside the converter of the system.The user decided to stop the procedure and evacuate the patient who was sedated.

Manufacturer Narrative

Philips investigated the converter and confirmed that an inside component (x2 capacitor) failed due to hospital main disturbances.Converters are ul 94 certified, and therefore any possible fire will self-extinguish.The replacement of both converters and wires in one converter solved the issue.

• 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: 7036481
• MDR Text Key: 92506079
• Report Number: 3003768277-2017-00096
• 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
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

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: 10/24/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• 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