Philips DL8740 Important Information Manual - Page 1

Philips DL8740 Manual

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February 2, 2018 Subject: URGENT MEDICAL DEVICE FIELD CORRECTION Dear Customer, A concern has been identified regarding the information provided with the Philips Ear Thermometer (DL8740) and Philips AVENT Smart Ear Thermometer (SCH740) ("Device"), that if it were to materialize, could pose risks for people being measured ('Patient'). This Field Safety Notice is intended to inform you about:  what the concern is and under what circumstances these risks can occur;  the actions that should be taken by the users of the Device in order to prevent risks to Patients;  the actions planned by Philips to mitigate the risks. This document contains important information for the continued safe and proper use of the Device. Please review the following information and share with all the users of the Device. It is important to understand the implications of this communication. Please retain a copy of this Field Safety Notice with the instructions for use of the Device. Philips has become aware of a number of complaints related to possible inaccurate measurements by the Device. Philips has identified that the risk of delaying treatment can have serious consequences for newborns (0-3 months), small children (4-36 months) and Patients of any age that may not be able to communicate and take care of themselves. In case a measurement shows a normal temperature value whereas the Patient actually has a fever, then that inaccurate measurement might lead to delayed or improper treatment of an underlying medical condition such as infection, which could result in Patient injury. ACTIONS TO BE TAKEN BY USERS  Philips advises users of the Device to only use the Device as directed in the instructions for use including the additional advice as per this Field Safety Notice  Philips advises users against relying on the Device as the sole basis for a decision seeking treatment and/or professional help  Users who wish to return the Devices based on the information provided in this Field Safety Notice can contact their local Philips product support representative HOW TO IDENTIFY AFFECTED DEVICES

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February 2, 2018
Subject: URGENT MEDICAL DEVICE FIELD CORRECTION
Dear Customer,
A concern has been identified regarding the information provided with the Philips Ear
Thermometer (DL8740) and Philips AVENT Smart Ear Thermometer
(SCH740) (“
Device
”),
that if it were to materialize, could pose risks for people being measured (
‘
Patient’
).
This Field Safety Notice is intended to inform you about:
what the concern is and under what circumstances these risks can occur;
the actions that should be taken by the users of the Device in order to prevent risks to
Patients;
the actions planned by Philips to mitigate the risks.
This document contains important information for the continued safe and proper use of
the Device.
Please review the following information and share with all the users of the Device. It is
important to understand the implications of this communication. Please retain a copy of this
Field Safety Notice with the instructions for use of the Device.
Philips has become aware of a number of complaints related to possible inaccurate
measurements by the Device. Philips has identified that the risk of delaying treatment can have
serious consequences for newborns (0-3 months), small children (4-36 months) and Patients of
any age that may not be able to communicate and take care of themselves. In case a measurement
shows a normal temperature value whereas the Patient actually has a fever, then that inaccurate
measurement might lead to delayed or improper treatment of an underlying medical condition
such as infection, which could result in Patient injury.
ACTIONS TO BE TAKEN BY USERS
Philips advises users of the Device to only use the Device as directed in the instructions
for use including the additional advice as per this Field Safety Notice
Philips advises users against relying on the Device as the sole basis for a decision
seeking treatment and/or professional help
Users who wish to return the Devices based on the information provided in this Field
Safety Notice can contact their local Philips product support representative
HOW TO IDENTIFY AFFECTED DEVICES