Events

Recall of Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-00179-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00179-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • 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 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.
  • Action
    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.

Device

Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors
  • Model / Serial
    Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors Module Version: E-NMT-01ARTG Number: 140216
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd