Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors 의 리콜

Recall

RC-2014-RN-00179-1

Class II

2014-02-19

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00179-1

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 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. module e-nmt-00 is unaffected by this issue.

GE Healthcare is advising users to do not use the E-NMT-01 module with ElectroSensor. The E-NMT-01 module can continued to be used with the MechanoSensor and Paediatric MechanoSensor. A software update will be provided to all affected users as a permanent correction. This action has been closed-out on 10/02/2016.