Events

Recall of qube Compact Monitor & XPREZZON Bedside Monitorqube Compact Monitor shipped between 16 December 2013 and 15 December 2014

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-2015-RN-00104-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00104-1
  • 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
    Spacelabs healthcare has received multiple reports regarding the following: - a failure to boot following power on or reset, resulting in monitor operation.- loss of network connectivity, which may result in;- an inability to display alarms and data from the affected monitor on central stations and other bedside monitors, or- a failure to transmit parameter and alarms from the affected monitor to system printers and sapcelabs’ intesys clinical suite retrospective database (including the clinical events interface remote notification feature).- display of english language when previously configured for another language (the alarm messages displayed in the parameter waveform zone are not affected as these are stored on a command module and not on the monitor.- touchscreen failure where touching the screen does not produce the expected response.This issue is caused by inadequate electrical contact on one of the printed circuit board assemblies.
  • Action
    A small number of printed circuit boards with the affected socket were also distributed to customers to facilitate repair of customer monitors. Medtel Pty Ltd will contact affected customers to schedule a convenient time to replace the PCBAs in in their facility. Meanwhile customers are advised the following: - The reported issues occur mostly at initial power on of a monitor. Always check for proper operation (such as functionality of touchscreen, proper language, and network connectivity) when the monitor is first turned on. - If the product is monitored via a central station, ensure the notification feature for monitoring communication loss is on. The capability is on by default. - If a bedside monitor is not monitored via central station, check the bedside monitor frequently to ensure the display is functional. - Do not rely solely on the monitor for critically ill patients. This action has been closed-out on 05/08/2016.

Device

qube Compact Monitor & XPREZZON Bedside Monitorqube Compact Monitor shipped between 16 December 2...
  • Model / Serial
    qube Compact Monitor & XPREZZON Bedside Monitorqube Compact Monitor shipped between 16 December 2013 and 15 December 2014Catalogue number: 91390ARTG number: 108755XPREZZON Bedside Monitor shipped between 18 June 2014 and 13 January 2015Catalogue number: 91393ARTG number: 181195
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA