澳大利亚治疗商品管理局（TGA）于上月末宣布暂停在新南威尔士州救护车队中使用的Corpuls 3和3T除颤器的销售，并可能取消其注册[1]。暂停期为三个月，将在两周内生效[1]。
根据调查，自2022年以来共报告117起与这两款设备相关的不良事件，其中包括31起伤害、5例死亡和20多起设备拒绝对患者进行电击的情况[1]。新南威尔士州救护车队在2025年记录了1129次该设备的故障，而该州仅配备1500台该设备[1]。
澳大利亚救护车协会主席Brett Simpson对官方声明表达了不满，称其"令人困惑"，并拒绝接受设备无问题的保证[1]。
Australia's Therapeutic Goods Administration (TGA) has suspended the sale of Corpuls defibrillators, models 3 and 3T, used in New South Wales ambulance fleets and may cancel their registration.[1] The suspension follows an investigation that revealed 117 adverse events reported since 2022, including 31 instances of patient injury, 5 deaths, and more than 20 cases in which the devices failed to deliver electrical shocks to patients.[1] The three-month suspension will take effect within two weeks.[1]
Concerns about device reliability have intensified following internal reporting from New South Wales ambulance services, which documented 1,129 device failures in 2025 alone—against a total fleet of approximately 1,500 Corpuls units in the state.[1] The TGA's action marks an escalation in scrutiny of equipment that has been deployed across the state since August 2022, when the New South Wales government announced a A$55 million contract with Device Technologies to supply the defibrillators.[1] Brett Simpson, president of the Australian Ambulance Association, has expressed skepticism about the official response, describing the announcement as "confusing" and refusing to accept assurances that the devices are without problems.[1]