Events

Recall of qube Compact Monitor (Transportable mutiparameter patient monitor)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtel 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-00712-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00712-1
  • 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
    There is a potential issue with the qube compact monitors that are “docking station ready” that have had a port cover plate removed allowing the monitor to be used with the optional qube docking station. if a docking station ready qube monitor is powered up undocked, connected to the network via an ethernet hardwire connection, and then disconnected from the ethernet hardwire connection and inserted into a qube docking station, a switch condition will cause the monitor to lose the network connection. all bedside alarms will continue to function normally.
  • Action
    If the users dock the monitor and lose network connection, power down the monitor and turn it back on to restore normal function. To prevent this error from happening, users are advised to avoid transitioning from hardwire ethernet connection to a docking station without powering down the device. Medtel Pty Ltd will contact affected sites to schedule a convenient time to correct the sites affected qube monitors.

Device

qube Compact Monitor (Transportable mutiparameter patient monitor)
  • Model / Serial
    qube Compact Monitor (Transportable mutiparameter patient monitor)Catalogue Number: 91390Serial Numbers: 1390-000290, 1390-000291, 1390-000337, 1390-000338, 1390-000339, 1390-000340, 1390-000607, 1390-000608, 1390-000609, 1390-000610, 1390-000689, 1390-000690, 1390-000691,1390-000692, 1390-000693, 1390-000695, 1390-100047, 1390-100048, 1390-101245, 1390-102559, 1390-102560, 1390-102561, 1390-102562, 1390-102563ARTG Number: 108755
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA