Schiller has issued a field safety notice for its Tempus LS defibrillator for impedance out of valid range and unexpected safety discharge.
The company received notice about an impedance change between a patient and the device that could cause an impairment of the impedance measurement. If the impedance is out of a valid range, defibrillation from the device is not possible. The problem can be caused by ground contact between the device and the patient, such as docking stations or wet floors.
Schiller recommends a hardware change to eliminate the possibility of an impedance impairment. The change has also been implemented on the latest Tempus LS defibrillator devices.
Tempus LS has also issued unexpected safety discharges, according to the field safety notice. The device can detect a voltage variation that can trigger the safety circuit to perform an internal discharge. Schiller made a hardware change to eliminate the issue.
The company recommends switching off the device and restarting if it shows unexpected safety discharge. Schiller also said it would provide a hardware modification to eliminate the issue and the Tempus LS defibrillator devices would need to be returned to the company for repair or exchange.
For both issues, Schiller recommends using another defibrillator until hardware modifications are performed.