Defibrillators banned in UK approved by TGA as device approvals come under scrutiny
A portable defibrillator device, the CellAED, has faced scrutiny after being banned in the UK for safety concerns while still being used in Australia. The article details a tragic incident where the device failed to function correctly during a cardiac emergency.
Why it matters
This case raises serious questions about the efficacy of medical device regulatory approval processes and the risks of consumer-grade life-saving equipment.
Entrepreneur Donovan Casey, the man behind the CellAED defibrillator. It has been pulled from use in Victoria and NSW and its manufacturer has collapsed. Mark Stehle Save You have reached your maximum number of saved items.
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Share A A A The married couple were at home when the emergency call arrived last November.
Their elderly neighbour, who lived two doors down in their quiet street, had collapsed from a suspected cardiac arrest.
The pair, who are health professionals, instinctively sprang into action. They grabbed one of their two new portable defibrillators and raced to their neighbour’s side.
The couple did not know the device had been yanked from the UK market more than a year earlier, after that nation’s regulator became concerned the CellAED was unsafe and ineffective.
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