Medical device manufacturer, Sentec AG, has issued a medical device safety alert concerning its Sentec Digital Monitor (SDM) (UDI-DI:07640121880018).
The manufacturer is initiating a field safety corrective action to inform customers regarding a non-compliance of the SDM with normative requirements from IEC 60601-1-11:2015 Medical electrical equipment when used in home environments.
The non-compliance is, that the SDM is a protection class I device while IEC 60601-1-11:2015 requires a protection class II device for use in the home healthcare environment.
According to the manufacturer, there have been no incidents or adverse events with regard to electrical safety issues, neither in home care environment nor in clinical environment. The benefit of monitoring patients at home outweighs the residual risks.
In order to operate this device, the manufacturer advises to use an isolation transformer with double insulation (2MOPP), which carries out the earth connection but isolates the mains voltage potential-free. Future orders of SDM with the intention to be used in home healthcare environment will automatically include the isolation transformer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your local supplier for necessary action.
Posted on 21 December 2020