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

Model Number 722026

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/12/2017

Event Type  Injury  

Event Description

Philips received a complaint where it was reported to philips that: a patient suffered from head-skin burn 3 months after the angiography procedure.Philips did not receive any further details.

Manufacturer Narrative

The patient was treated on (b)(6) 2017.The system is under service contract with a philips distributor in (b)(4).The distributor has provided philips with all available service reports, performed tests and information from the field service engineer (fse) who checked the system on site.The distributor¿s fse confirmed that he tested the system on 2017aug19 and the outcome showed that the system was working within specifications except for the grid switch test which failed.In the presence of a grid switch failure the system will ensure that the entrance dose rate will be reduced and that the issue will not result in increased dose for the patient.According to the distributor¿s fse the customer was aware about the grid switch error.To correct this, the tube needs to be replaced.As far as we know, customer has not replaced it.The available system test results and other information was analyzed by a philips igt product designer who concluded that the system is working within specification and all necessary calibrations were performed and passed for all dose relevant tests.Not enough information has been provided to estimate or calculate the dose received by the patient, and if the dose received is related to the skin burn reported by the customer.Based on the information provided, no malfunction of the system has been confirmed that could have led to the skin burn reported.Therefore , no further actions will be taken by philips.

• 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: 7058910
• MDR Text Key: 92932764
• Report Number: 3003768277-2017-00101
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

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: 722026
• Device Catalogue Number: 722026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2014
• 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