The TGA has revoked the suspension of the Philips IntelliVue MX40 wearable patient monitor in accordance with section 41 GD of the Therapeutic Goods Act 1989 on 16 November 2017.
In recognition of the high rates of speaker failure for devices utilising an older version of the speaker, Philips Electronics Australia Ltd., had agreed to undertake a recall and replacement of all affected units supplied in Australia. The subsequent recall action, TGA recall reference RC-2017-RN-00732-1, saw the replacement of affected devices with devices utilising an improved hardware speaker and updated software including speaker detection capability.
Satisfactory progress has been and continues to be made by the manufacturer towards addressing the TGA's concern on device safety and performance. The TGA will continue to monitor the rate and incidences of adverse events, and of device or component failures.
Information for health professionals
We recommend that hospital staff continue to carry out routine testing and maintenance on these devices, and to observe 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 speaker fails during the self-test or in monitoring mode, please do not use and seek a replacement.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS).
Suspension - safety concerns
16 May 2017
Consumers and health professionals are advised that the TGA 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 (Information Centre) 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.
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.
Information for consumers
Philips IntelliVue MX40 wearable patient monitors are used only in hospital settings.
If you or someone you provide care for is hospitalised and needs monitoring, please be aware that the health professionals who work in these areas are highly trained and have protocols to deal with the potential issues that may affect these devices.
If you have any questions or concerns about this issue, speak to the hospital staff.
Information for health professionals
The TGA does not recommend that Philips IntelliVue MX40 wearable patient monitors currently being used in hospitals be taken off service.
However, 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.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.