Events

Recall of Xhibit Central Station (patient monitoring system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ecomed 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-2016-RN-00572-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-05-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00572-1
  • 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
    The manufacturer, spacelabs, has received one report of values for patient height and weight being switched when input at the xhibit central station, causing a bedside monitor body surface area (bsa) calculation to be in error. no one has been injured due to this error. in order for the error to occur, the height and weight values must have been entered at the xhibit central station, the cardiac output cable must be attached for use, and the cardiac output function on the bedside monitor must be initiated. the bsa value is determined by the monitor from height and weight of the patient and is used in subsequent hemodynamic calculations such as cardiac index. the bedside monitor also contains a “drug calculator” for computation of drug dose conversions by weight or other units of measure. in situations where the failure mode has occurred, this initial value will not be accurate due to the height and weight transposition.
  • Action
    Ecomed is providing users with work around instructions to follow as an interim measure. Affected customers will be provided with a software upgrade as a permanent correction. This action has been closed-out on 27/01/2017.

Device

Xhibit Central Station (patient monitoring system)
  • Model / Serial
    Xhibit Central Station (patient monitoring system)Model Number: 96102Serial Numbers: SLA1114F00831, SLA0114F00450ARTG Number: 237776
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Ecomed Pty Ltd

Manufacturer

Ecomed Pty Ltd