A whistleblower tried twice to warn Australia’s medical regulator about false claims made by a defibrillator maker, but officials took no action.
It can also be revealed that the CellAED defibrillator had been tested only on two pigs when its Australian manufacturer, Rapid Response Revival, applied for approval. Yet far from restarting their hearts, the device electrocuted both animals.
The developments heap fresh pressure on the Therapeutic Goods Administration (TGA), after this masthead’s Medical Malfunctions investigation revealed weak laws were allowing medical devices such as the CellAED to be sold with no human evidence showing they worked or were safe.
The Medical Malfunctions investigation used automated website scrapers to crack open the TGA’s database and extract about 81,000 publicly available reports detailing adverse-event reports submitted to the regulator since 2012.
Medical Malfunctions has already highlighted issues with the operation and regulation of devices such as glucose monitors and insulin pumps used by hundreds of thousands of Australians, spinal pain pumps and heart surgery machines.
A former executive at Rapid Response Revival alerted the TGA twice – in 2019 and 2021 – that the CellAED manufacturer was deceiving Australians and potential investors.
“This company continues to raise funds...
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