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Australia suspends sale of corpuls defibrillators used in ambulances
The Therapeutic Goods Administration (TGA) has suspended the sale of corpuls model 3 and 3T defibrillators, which are currently utilized in ambulance fleets across New South Wales, South Australia, and Western Australia. The suspension follows reports of significant malfunctions during life-saving procedures.
Paramedics have reported several critical failures, including devices switching off during resuscitation, discharging shocks without delivering them to the patient, and failing to deliver a shock when prompted. Data analyzed by investigators indicates that since 2022, there have been 117 adverse events linked to these devices, including five deaths, 31 injuries, and over 20 instances where the devices refused to shock patients.
While the TGA has stated that suspensions occur to address safety, quality, or performance issues, the regulator has not provided specific details regarding the grounds for this action. The Australian Paramedics Association has expressed concern over the lack of clarity and the potential impact on patient safety while these devices remain in active service.
Entities
Australian Paramedics Association · New South Wales · Therapeutic Goods Administration · corpuls