Product group Medical electronics / Electromedical devices
Reference 01891/11, 01892/11

GE Healthcare has issued a Field Safety Notice of two potential safety issues associated with the CARESCAPE™ Monitors B850 and B650.

1. When the CARESCAPE Monitor B850 is used to measure Cardiac Output values with the Patient Data Module (PDM) or TRAM Module, Cardiac Output values may be calculated incorrectly if the default catheter settings are used.
2. The ECG “Leads Off” alarm may not be activated with a specific user workflow.

Safety Notice for Carescape Monitors B850 and B650, GE Healthcare FinlandOy , Download_VeroeffentlichtAm_EN 2011.04.29 PDF, 102KB, File does not meet accessibility standards