| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00179-1 |
| Product Name/Description |
Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors
Module Version: E-NMT-01
ARTG Number: 140216 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |