Medical device manufacturer, Remote Diagnostic Technologies Ltd., has issued a medical device safety alert concerning its Tempus LS [REF: 00-3010; UDI-DI: 07613365001693] with software version 1.3.4.
According to the manufacturer, a software error has been detected as part of internal production control activities for the Tempus LS. This issue affects all Tempus LS products with Software Version 1.3.4 installed.
There is a risk when exiting Pacer mode back into Manual mode or AED mode, that the pacer pulse wave may put the ECG calibration out of calibration. This causes the waveform display to be a flat line, mimicking asystole. This situation will occur when the user exits Pacer mode at the exact moment to coincide with a pacing pulse. The higher the pacing pulse rate frequency the higher the likelihood of occurrence. The incidence rate of the software error occurring is approximately 2-3% of mode changes from Pacer Mode to Manual Defibrillation Mode or Pacer Mode to AED Mode.
For devices at V1.3.4, when changing from Pacer mode to either Manual defibrillation mode or AED mode, affected user must manually exit Pacer mode into the default (Manual or AED mode) and then must power cycle the device by holding the power button to turn the device off and then power on again using the power button. The device will restart in the default Manual or AED defibrillation mode.
The manufacturer identified this as a software problem and a fix will be made available in Tempus LS Software Version 1.3.5. by the distributor.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 10 December 2020