GE Healthcare Finland Oy, FSN-FMI 39004, TruSignal® SpO2 Sensors

Issue 1: Affected TruSignal SpO2 Sensors (see Table 1 below) can potentially reduce the amount of electrical energy reaching the patient during external defibrillation, which could limit successful defibrillation and restoration of a normal rhythm. If this issue occurs during an external defibrillation event, it could go unnoticed by the caregiver and could contribute to an adverse patient outcome.
Issue 2: Affected TruSignal SpO2 Sensors (see Table 1 below) that have been saturated with fluids, can expose the patient to unintended voltage if the patient comes in contact with a faulty external power source while wearing the affected sensor. This could contribute to an adverse patient outcome.