Device product
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.
Z-1292-2018
Product summary
- Event
- Event 79464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1742
- Official record key
device-enforcement:Z-1292-2018
Official wording
Reason: if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).
Code information: Model # - 107-PT-020 ( all units distributed from January 2016- November 2017)
Distribution pattern: Worldwide - US Nationwide Distribution.
Derived failure modes
-
Unknown
if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).