Australia’s TGA kept CellAED defibrillator on market after UK withdrew certification

The device was approved in Australia in 2021 after a private German assessor found it comparable to an existing defibrillator, despite delivering only 85 joules of energy. The TGA accepted the German finding without conducting its own review of human clinical evidence.

Device performance and incidents In November 2025 a Melbourne couple used one of the units on a neighbour experiencing cardiac arrest. The device took approximately 50 seconds to deliver a shock, and the shock passed through the patient into the wife, who was 23 weeks pregnant.

The neighbour briefly regained a pulse but died after paramedics arrived. The TGA database contains 22 adverse-event reports for the CellAED, six of which describe the device failing to shock patients who later died. Ambulance Victoria and the ACT ambulance service have removed the units from service.

” The British Standards Institution withdrew the device’s certificate in 2024. A TGA spokesperson stated that manufacturers are responsible for holding clinical evidence and that the agency conducts targeted post-market monitoring. The TGA became aware of the UK concerns in 2023 but did not cancel the Australian registration until the manufacturer withdrew it in February 2026.

Associate Professor Elizabeth Paratz, a cardiologist at St Vincent’s Hospital in Melbourne, said the device was imperfect but better than nothing in situations where standard defibrillators are unavailable.