Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration

Philips Electronics Australia Limited ABN 24 008 445 743 is the supplier in Australia of the HeartStart MRx, a professional defibrillator that is used to pace people with a slow heartbeat, or to deliver life-saving electrical shocks to people with sudden cardiac arrest.

The HeartStart MRx is a medical device within the meaning of Chapter 4 the Therapeutic Goods Act 1989.

Philips advised in May 2017 that the HeartStart MRx will no longer be supplied. Although removed from the Australian Register of Therapeutic Goods on 19 July 2017, the HeartStart MRx continues to be used and fully supported in hospitals, private clinics and ambulance fleets across Australia to save lives.

Philips has entered into a Memorandum of Understanding with the TGA in which it has agreed to notify any actual or anticipated shortages of accessories, repair parts and consumables of the HeartStart MRx in Australia until 31 December 2022 and to remedy them as soon as reasonably practicable. Philips will meet with the TGA twice yearly over the life of the MoU and will, like all sponsors of medical devices included in the Australian Register of Therapeutic Goods, continue to report adverse events and near adverse events to the TGA in accordance with the TGA's Australian Regulatory Guidance for Medical Devices and to comply with the Therapeutic Goods Act 1989.

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).