Events

Recall of Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilities

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-01172-1
  • 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-01172-1
  • 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 the following issues:- the 12-lead standard and extended measurement report will include false measurements when the p wave or qrs axis cannot be accurately determined by the algorithm. - the median complex and extended measurement report will display the representative beat as 25% larger than actual signal input. - when a patient date of birth is imported into the v-series from an external source, such as mindray’s gateway, e-gateway, panorama central station or panorama workstation, the age will not pass into the 12-lead ecg interpretation algorithm. the algorithm analysis will use the default adult criteria of “50 year adult” in which case the interpretive statements may be incorrect, depending on the actual age of the patient. any output of the 12-lead ecg interpretation data (e.G. printed records, ecg management system, etc.) will include the issues described above. there have been no reports of injuries associated with these issues.
  • Action
    Mindray is recommending that users discontinue use of the affected units until the software correction is completed. This action has been closed-out on 26/08/2016.

Device

Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilities
  • Model / Serial
    Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilitiesV-series Model Numbers: 1409 & 1410Serial Numbers: EGD16006409, EGD13004678 & EGD0B002460ARTG Numbers: 223384
  • Manufacturer
    Ulco Engineering Pty Ltd

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA