URGENT - Field Safety Notice
Contents
1. this problem Sincerely H de Jong Sr Director Q amp R BIU iXR KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner Form UXW 060003a2 2007 12 18 PHILIPS Field Safety Notice Philips Healthcare PHILIPS BIU iXR 2 2 FSN MA FCO 72200237 XCR603 130267 tv October 2013 URGENT Field Safety Notice Philips HaemoSphere R4 1 Calculation of the vascular resistances in the Philips HaemoSphere R4 1 evo natal ped in the special case of a shunt vitium Software update and IFU update AFFECTED PRODUCTS System Philips HaemoSphere R4 1 Productcode 722060 PROBLEM DESCRIPTION The software of the Philips Haemo 4 1 calculates lesser circulation resistance RP and RPI from the difference between the mean pulmonary arterial and pulmonary venous pressure or LA mean pressure divided by the heart minute volume This calculation method leads to a correct result except in the special case of a shunt vitum In this case the calculation method that is used can lead to an incorrect calculation of pulmonary resistance This contradicts the information in the user manual HAZARD INVOLVED As a result clinical users could incorrectly consider the calculated pulmonary resistance valid even in case of a2. 0 KONINKLIJKE PHILIPS ELECTRONICS N V 2008 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner Form UXW 060003a2 2007 12 18
3. PHILIPS Field Safety Notice pD 4 j LI DS Philips Healthcare BIU iXR 1 2 FSN MA FCO 72200237 October 2013 XCR603 130267 tv URGENT Field Safety Notice Philips HaemoSphere R4 1 Calculation of the vascular resistances in the Philips HaemoSphere R4 1 evo natal ped in the special case of a shunt vitium Software update and IFU update Dear Customer A problem has been detected in the Philips HaemoSphere R4 1 Haemodynamic Catheter measuring station that will lead to an incorrect calculation of the pulmonary resistance This Field Safety Notice 72200237 is intended to inform you about e what the problem is and under what circumstances it can occur e the actions that should be taken by the customer user in order to prevent risks for patients or users e the actions planned by Philips to correct the problem This document contains important information for the continued safe and proper use of your equipment Please review the following information with all members of your staff who need to be aware of the contents of this communication It is important to understand the implications of this communication Please retain a copy with the equipment Instruction for Use If you need any further information or support concerning this issue please contact your local Philips representative 0800 80 3000 This notice has been reported to the appropriate Regulatory Agency Philips apologizes for any inconveniences caused by
4. shunt vitium With the exclusive uncritical evaluation of this parameter therapeutic decisions based on it could be incorrect HOW TO IDENTIFY AFFECTED PRODUCTS All Philips HaemoSphere R4 1 systems as indicated in the Affected Products section mentioned above A Unit Affected List UAL is provided to the local Philips representatives Customers with affected systems will be contacted directly by the local Philips Organization ACTION TO BE TAKEN BY CUSTOMER USER The calculation for the vascular resistances may not be used in the presence of a shunt vitium ACTIONS PLANNED BY PHILIPS A Mandatory Field Safety Corrective Action will be issued to solve this problem This Field Change Order FCO will be identified as FCO72200237 and will be free of charge e This FCO consists of a SoftWare update which in cases where a shunt calculation was previously performed ensures that the specific flows determined using the shunt calculation are used for the resistance calculation so that in this case the vascular resistances can also be determined correctly even in the presence of a shunt vitium e This FCO consists of an IFU update with a corrected text of the Chapter Vascular resistances The expected date of this FCO will be Q4 2013 FURTHER INFORMATION AND SUPPORT If you need any further information or support concerning this issue please contact your local Philips representative 0800 80 300
Download Pdf Manuals
Related Search