URGENT - Medical Device Correction IntelliVue MX40 Missing Warnings in IFU

Transcription

1 Dear Customer, A problem has been found with the Philips IntelliVue MX40 Instructions for Use (IFU) for software revisions B.05, B.06 and B.06.5X. Your IntelliVue MX40 remains safe to use. These IFUs are missing warning statements related to monitoring paced patients and the interpretation of QT/QTc measurements that were present in earlier revisions of the IFU. A Warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. This Field Safety Notice is intended to inform you about: what the problem is and under what circumstances it can occur the actions that should be taken by the customer/user in order to prevent risks for patients 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 refer to the following pages, which provide information on the missing warnings and instructions for actions to be taken. Follow the Action to be taken by Customer/User section of this notice. This issue has been reported to the appropriate regulatory agencies. I sincerely regret the inconvenience that this may cause you. Your satisfaction with Philips products and with our response to this issue is very important to us. Please contact your local Philips representative under with questions or concerns about this correction. Sincerely, Kristen Phillips Head of Quality & Regulatory Affairs, Andover

2 AFFECTED PRODUCTS The Philips IntelliVue MX40 revisions B.05, B.06 and B.06.5X. Model Product Number IntelliVue MX PROBLEM DESCRIPTION HAZARD INVOLVED HOW TO IDENTIFY AFFECTED PRODUCTS ACTIONS PLANNED BY PHILIPS Five warning statements are missing from the IntelliVue MX40 IFU for software revisions B.05, B.06 and B.06.5X. If users are unaware of the hazards or limitations described in the missing warning statements, they may not properly assess or provide appropriate treatment to a patient being monitored using an IntelliVue MX40. IntelliVue MX40 Instructions for Use for software revisions B.05, B.06 and B.06.5X. Philips is voluntarily initiating a correction consisting of: Distribution of this Field Safety Notice (). Release of an IFU Errata that provides the missing warnings A representative will contact customers with affected IFU revisions to provide a copy of the errata. This FSN includes the Errata providing the missing warning statements. ACTION TO BE TAKEN BY CUSTOMER / USER The enclosed MX40 IFU Errata Sheet must be attached to the first page of Chapter 6 of the Instructions for Use for ready reference. Complete and return the attached Customer Reply Form.

3 Contact Name Telephone Number Address Facility Name Street Address City, State, Zip Customer Reply for IntelliVue MX40 IFU Please complete and fax to Please fax or this completed form to the number or address provided above. CUSTOMER ACKNOWLEDGEMENT: The MX40 IFU Errata must be attached to the first page of Chapter 6 to ensure that it is not misplaced and is stored with the Instructions for Use for ready reference. CUSTOMER NAME (please print) TITLE CUSTOMER SIGNATURE DATE Please fax or the completed reply form to customercare.ch@philips.com. If you experience difficulty carrying out the instructions contained in this communication, contact your local Philips representative:

4 IntelliVue MX40 Release B.05 or Later Instructions for Use Errata This Errata is a supplement to the IntelliVue MX40 Instructions for Use Release B.05 and later. It contains important safety information. Attach this Errata to the first page of Chapter 6 to ensure that it is not misplaced and is stored with the Instructions for Use for ready reference. Part Number Printed in the U.S.A. First Edition * *

5 6 ECG and Arrhythmia Monitoring English 6 ECG and Arrhythmia Monitoring ECG Safety Information Warning The device provides QT and QTc interval change information; the clinical significance of the QT and QTc interval change information should be determined by a clinician. For more information, see the QT Interval Monitoring Application Note, p/n For Paced Patients Warning The output power of the MX40 and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance. Due to the shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patient. In order to minimize the possibility of interference, position electrodes, electrode wires, and the MX40 as far away from the pacemaker as possible. Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the MX40. See the Patient Information Center Instructions for Use for additional information on monitoring paced patients. When an external pacemaker is being used on a patient, arrhythmia monitoring is severely compromised due to the high energy level in the pacer pulse. This may result in the arrhythmia algorithm's failure to detect pacemaker non-capture or asystole. Pacemakers that create fusion beats (pace pulse on top of the QRS complex) cannot be detected by the monitor's QRS detector. For paced patients who exhibit only intrinsic rhythm, the monitor can erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest. The risk of missing cardiac arrest can be reduced by monitoring these patients with the low heart rate limit at or slightly above the basic/ demand pacemaker rate. A low heart rate alarm notifies you when the patient begins pacing. Proper detection and classification of the paced rhythm can then be determined. Note During defibrillation, monitoring may be temporarily interrupted or distorted. It may take several seconds for the ECG trace to reappear on the screen. After defibrillation, the device will continue to monitor as before; the device settings will not be affected. 6-1