Novii Wireless Patch System for maternal and fetal monitoring

Regulatory information

Novii Wireless Patch System is a CE-marked class IIb in vitro diagnostic.

The following manufacturer field safety notices or medical device alerts for this technology have been identified:

Monica Healthcare: Monica Novii Wireless Patch System, Medicines and Healthcare products Regulatory Agency field safety notice (May 2017). A potential safety issue was identified when leaving the Novii Wireless Patch System plugged in and charging, unattended and not in clinical use, for days or weeks. The issue was resolved by releasing a software update and confirming all affected units in the field were upgraded free of charge.

Monica Healthcare: Monica Novii Wireless Patch System, Medicines and Healthcare products Regulatory Agency field safety notice (December 2017). A potential safety issue was identified that can happen if the interface cables of Novii Wireless Patch System are removed, and then incorrectly reconnected. The instructions and labelling describe the correct procedure for connecting the 3 interface cables to the Novii Interface System. This issue was resolved by providing screws and instructions that replace the user-accessible thumb screw hardware, with hardware that needs a screwdriver to apply and remove.