Events

Recall of Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring Network

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ulco Engineering 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-01158-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01158-1
  • 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
    Mindray has identified an issue related to the panorama central station where full disclosure data (includes patient data, waveforms, and events) may lag behind the panorama system time clock when the panorama central station is in use with mindray’s v-series monitor. the full disclosure data may be a minimum of 6 seconds behind the panorama system time clock and may grow at a rate of 5 to 7 seconds per day if the v-series monitor remains connected to the panorama central station without interruption. this issue may also lead to the inability to print the most recent “full disclosure” data if the lag time exceeds 21 seconds. if the lag time exceeds 30 seconds, non-invasive blood pressure measurement contained in the “list trends” may appear out of time order. there are no reports of injuries associated with these issues.
  • Action
    Mindray is arranging software upgrade to eliminate this issue. Customers are advised that a break in communications, admitting or discharging a patient or putting the V-Series in standby will, temporarily, eliminate the issue. This action has been closed-out on 26/08/2016.

Device

Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring Network
  • Model / Serial
    Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring NetworkSerial Number: RM01940-F2ARTG Numbers: 223386
  • Manufacturer
    Ulco Engineering Pty Ltd

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA