TGA Pulls Philips’ IntelliVue MX40 Patient Monitors

Australia’s Therapeutic Goods Administration has suspended Philips’ license for its IntelliVue MX40 wearable patient monitor after repeated speaker failures.

The monitors are worn by patients in hospitals to record and generate alarms for heart rate, oxygen saturation and other functions. The agency determined that the device could fail in certain situations, particularly when the patient is being moved and the monitor is not connected to the fixed display unit.

The company will not be able to market the product in Australia until the problem is fixed. But the agency recommended not removing monitors that have not been problematic.

The device is manufactured by Philips Medical Systems in the United States and is supplied to Philips Australia and New Zealand.