Defibrillators in our ambulances randomly shut down, TGA admits

The medical watchdog has broken its silence over its move to suspend troubled ambulance defibrillators – revealing unexpected shutdowns were behind the decision.

After repeated criticism from political leaders over a lack of transparency about the suspension, the Therapeutic Goods Administration on Wednesday said on its website that the issue centred on the devices randomly shutting down and rebooting.

The agency issued safety alerts in 2024 and 2025 – including one where a “reasonable possibility of serious injury or death was flagged” – about the corpuls shutting down during patient care, leaving them without defibrillation for up to 60 seconds.

The 2025 issue was meant to be “closed out” by July this year.

“These products were suspended whilst investigations continue into reports of unexpected device shut down and rebooting during use,” the TGA said on Wednesday. “Actions to reduce the risks associated with these issues have been communicated to users by the sponsor, and are published on the TGA website.

“The TGA has requested documentary evidence to further demonstrate the effectiveness of those actions, including software-related reboot issues, as well as the adequacy of the systems and processes it uses to identify, investigate and respond to future device-related issues and non-conformances in a timely manner.

“A suspension does not represent a finding that the devices are unsafe.

“Defibrillators in Australian ambulances and healthcare facilities continue to be safe to use. The TGA has not issued a recall of these devices.”

Brett Simpson, NSW President of the Australian Paramedics Association said the software issue was one of many facing paramedics using the device. “Sure they shut down mid-resuscitation, but it’s one of 10 or 12 issues,” he said.

The TGA also said it would be launching a consultation process on increasing transparency around medical device suspension.

That comes after the NSW government demanded an explanation from the health watchdog over its suspension on the sale of the defibrillators used in the state’s ambulances.

“I’ll be writing to the TGA to see if they could give us a little bit more information,” Health Minister Ryan Park said. “They’ve made a decision not to disclose the details … that can be a little bit frustrating.”

The corpuls defibrillator has been the subject of 16 market actions by the TGA since 2012.

The government and NSW Ambulance continue to assert that the devices are safe for patient use, despite widespread complaints from paramedics, including reports of the device failing to discharge a shock.

On Tuesday this masthead revealed that a senior NSW Ambulance figure told staff that the corplus 3 and corplus 3T defibrillators recorded 1229 failures in 2025 alone.

Park said that “not all of those have been serious failures. It could be a lead not working. It could be a range of different areas”.

“I’m still confident, based on the advice of the NSW Ambulance … as well as the TGA, that this should remain in our ambulances and form a part of the life-saving equipment that we have for people,” he said.

NSW opposition health spokesperson Sarah Mitchell said it was “pretty concerning that the health minister hasn’t been made aware already by the TGA what the major concerns are”.

Marty Nichols, Ambulance NSW’s associate director of clinical practice, sympathised with paramedics who had raised concerns about the devices on an internal forum of more than 4000 members, where he said they had a “right to be disappointed”.

Nichols, responding to one of the hundreds of comments from paramedics about the $30,000 defibrillators, said in his post that while paramedics at large stations might hear of failure “almost every day”, that should be weighed against the 1.5 million callouts every year.

Alan Morrison, NSW Ambulance’s executive director of clinical capability, said these complaints did not represent failures, but a “range of technical issues in a complex piece of machinery”.

“We’re not talking about a large number of defibrillation failures … we have not identified any safety issues impacting on patients,” he said. “However, our staff, as they should as clinicians, raise these technical issues as they arise. They are a thing we need to look into and address.”

He said there were various issues reported, including those related to the defibrillator’s connection to its leads.

This masthead has also obtained a series of posts from paramedics complaining about problems with the device. The South Australian ambulance union has also raised concerns.

NSW Greens health spokesperson Dr Amanda Cohn said defibrillators were the “single most time sensitive piece of equipment in an ambulance.

“If a defibrillator fails, waiting for a back-up from another ambulance could cost a life,” she said, and called for NSW Ambulance to move to a different device and bring their tender process forward, rather than waiting for the devices’ contract to expire in six years’ time.

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