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

Model Number 722005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Burn (1755)

Event Date 03/03/2014

Event Type  Injury  

Manufacturer Narrative

Philips is in the process of obtaining more information about the patient outcome.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 a patient was treated in the electro physiology department.The patient developed a radiation burn after extend ep study.The patient had two studies within a couple weeks of each other.The last study had a total of 275 minutes of fluoro time.The procedure took place on 2014 march 3, but philips was informed about the event on (b)(6) 2017.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: the high x-ray dose of 31 gy for the patient at (b)(6)2014 can be explained by the length and intensity of the examination.The total duration of this examination was about 6 hours (from 9:49 till 15:56).The total fluoro time was 275 minutes (4 hours and 35 minutes).During the whole examination biplane fluoro was used, and only a few cine runs.The philips field service engineer and the investigator who checked the log files were unable to identify a malfunction of our allura xper fd10/10 system.No malfunction of the philips system has been identified based on the available information.The performed procedure had a very long duration.In addition, the customer barely moved the system, which means that almost all the time the same body part of the patient was exposed.Taken together, the long duration of the procedure and the long total fluoroscopy time are causing the high ak of 31 gy for this examination and contributed to the development of a radiation burn.

• 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: 6562875
• MDR Text Key: 75015845
• Report Number: 3003768277-2017-00047
• 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: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 722005
• Device Catalogue Number: 722005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 04/21/2017
• Supplement Dates FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2008
• 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
• Patient Outcome(s): Other