Device product
Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.
Z-1293-2018
Product summary
- Event
- Event 79464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 355
- Official record key
device-enforcement:Z-1293-2018
Official wording
Reason: if the cables of the Monica IF24 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 # - 105-PT-001 ( all units distributed from October 2011 - May 2016)
Distribution pattern: Worldwide - US Nationwide Distribution.
Derived failure modes
-
Unknown
if the cables of the Monica IF24 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).