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© Philips Elektronikproduktion | 16 Mai 2017

Philips: 'Wir arbeiten mit TGA an einer Lösung'

Nach dem Verkaufsstopp der Philips IntelliVue MX40 Geräte in Australien hat das Unternehmen angegeben, eng mit TGA zusammenzuarbeiten, um die bestehenden Probleme zu klären und zu lösen. Im Folgenden finden Sie die gesamte Stellungnahme von Philips:
The communication from the TGA on the suspension of the Philips IntelliVue MX40 Patient Worn Monitor in Australia relates to reports of failure of the device’s speaker and Philips’ actions in response to those reports. This failure does not impact any other features or functionalities of the device. Philips regards this matter with the utmost seriousness, and we are dedicated to providing safe and effective medical devices to our customers and their patients who rely on them.

Philips is in discussion and working closely with the TGA to clarify and resolve this matter. We are committed to full adherence to all regulations and laws concerning medical devices. There were a total of 65 reportable complaints in Australia in the three years of data that was requested by the TGA in the period of April 25, 2014 – April 25, 2017. Philips has investigated and reviewed this issue and is putting in place all the appropriate steps in line with TGA guidance for devices currently in the market. The TGA is not recommending that units that have not demonstrated this problem be taken off service while the corrective action takes place. We can confirm that there are over 2000 devices present across a number of hospitals in Australia.

In the past few years, we have also received some reports of failure of the Philips IntelliVue MX40 Patient Worn Monitor’s speaker in other markets. Philips has addressed these reports adequately and where appropriate also been in touch with the relevant local regulator.

Through continuous process improvements, Philips has addressed the speaker issue and improved the design of the device. These changes have resulted in very low or non-existent speaker failure reports for newer devices.

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