Events

Recall of Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Engstrom Carestation, Patient Monitor B30, S/5M and FML 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-00543-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00543-1
  • 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
    Ge healthcare has become aware of a potential safety issue due to failure of the carbon dioxide detector associated with single-width airway and extension modules. failure of the carbon dioxide detector in single-width airway and extension modules may cause a slow continuous decrease of measured et-/fico2 values. incorrect et co2/fi co2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low co2 values.
  • Action
    GE is providing calibration instructions to assist their customers to determine if their module is affected. If the carbon dioxide reading is out of range after the first successful calibration procedure end users are advised to discontinue use and contact a GE service representative. GE will arrange with customers for a correction to ensure this issue does not occur. This action has been closed-out on 02/02/2016.

Device

Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Moni...
  • Model / Serial
    Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Engstrom Carestation, Patient Monitor B30, S/5M and FML monitors)Single-width Airway Module E-miniCSerial Numbers: 6818561 to 6898777Extension Modules N-FC & N-FCRECSerial Numbers: 6799191 to 6905206ARTG Number: 166230
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd