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© Philips Business | May 16, 2017

Sale of Philips IntelliVue MX40 suspended in Australia

Australia's Therapeutic Goods Administration has suspended the sale of Philips IntelliVue MX40 wearable patient monitors, after numerous reports of speaker failure.
EDITOR'S NOTE_ We received a statement from Philips saying that they are taking the issue seriously and are working - together with TGA - to resolve it as soon as possible. Please follow this link.

The TGA, Australia's medical devices watchdog, has suspended the licence to supply Philips IntelliVue MX40 wearable patient monitor after identifying a significant increase in reports of speaker failure incidents associated with the device.

Philips IntelliVue MX40 wearable patient monitors are worn by patients in hospitals. It monitors, records and generate alarms for the patient’s heart rate, oxygen saturation and other physiological parameters, and relays the information to a central station that is monitored by clinical staff. It can also be used off network in monitoring mode, for example during patient transport.

It is manufactured by Philips Medical Systems in the USA and supplied in Australia by Philips Australia and New Zealand, under Australian Register of Therapeutic Goods entry 99204.

Investigation of the reports received by the TGA has found that "it is possible that the device will not sound an alarm in critical situations". The likelihood that this will occur is low, but "is still considered to be unacceptable under the circumstances, especially when the device is not connected to the Information Centre", a press release states.

Philips Australia and New Zealand will be unable to supply new Philips IntelliVue MX40 wearable patient monitors to the Australian market until the problem is fixed, both in new and existing devices.

However, due to the critical need for patient monitors in hospitals and the impracticality of replacing existing devices, the TGA is not recommending that units that have not demonstrated this problem be taken off service while the corrective action takes place.

"We recommend hospital staff carry out routine testing and maintenance on these devices, and to pay extra attention during the power on self-test (POST) that all aspects of device function, including screen alerts and audio speakers, are working as intended before using for monitoring patients and off-network use. If the device speakers fails during the self-test or in monitoring mode, please do not use and seek a replacement", the notice continues.

EDITOR'S NOTE_ We received a statement from Philips saying that they are taking the issue seriously and are working - together with TGA - to resolve it as soon as possible. Please follow this link.

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October 16 2017 2:56 PM V8.8.6-1