Events

Recall of Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable 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-2012-RN-01136-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01136-1
  • 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 failure of the qube compact monitor where the input power can fail even though the power source at the wall has not been interrupted. the monitor automatically goes into battery mode and functions normally, including the low battery alerts, until the batteries become depleted and the monitor turns off. in addition, there is the potential for the qube compact monitor to fail to turn on.
  • Action
    As an interim measure, Medtel is providing work around instructions to reduce the probability of occurrence. New hardware will be installed to permanently correct the issue as soon as possible.

Device

Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor)
  • Model / Serial
    Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor)Serial Numbers:1390 - 000340, 1390 - 000339, 1390 - 000338 & 1390 - 000337ARTG Number: 108755
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA