Company: GE Healthcare
Date of Enforcement Report:5/28/2014
Class lI:
PRODUCT
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. The device is indicated for use by qualified medical personnel only.
Recall Number Z-1640-2014
REASON
When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual amount of movements. This issue may lead to an inadequate dose of muscle relaxants. This issue may occur when the E-NMT-01 module is plugged into the CARESCAPE or the Datex-Ohmeda S/5 Anesthesia monitor.
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI on 4/9/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1727p>
DISTRIBUTION
Nationwide and Internationally
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