GE—Integrated ECG Cables: May Short Circuit during Defibrillation and Conduct 25% of Defibrillation Energy Away from the Patient
March 6, 2019 | Risk Management News
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In an Urgent Field Safety Notice letter posted by the German Federal Institute for Drugs and Medical Devices (BfArM), GE states that the above cables may short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient. If this problem occurs during a defibrillation event, it is not noticeable to the caregiver and could contribute to an adverse patient outcome. GE also states that it has received...