Events

Safety Alert Or Field Safety Notices for IntelliVue patient monitors used with 12-lead ECG

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Philips Healthcare.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2017/031
  • Date
    2017-09-28
  • Event Date Posted
    2017-09-28
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/intellivue-patient-monitors-used-with-12-lead-ecg-risk-of-ecg-trace-distortion-specific-models-and-software-versions-affected
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by philips healthcare: error messages reporting a damaged or incorrectly functioning cable can trigger automatic corrective filtering of the ecg trace, distorting the st segment, leading to risk of misinterpretation or misdiagnosis. (mda/2017/031).
  • Action
    Identify affected devices, which are listed in the Field Safety Notice. Ensure that users understand and follow the instructions in the Field Safety Notice, in particular, the advice for correctly responding to ‘ECG Check Cable’ or ‘ECG Noisy Elec xx’ error messages. Ensure a Philips Healthcare representative arranges to install the software upgrade as soon as it becomes available. Contact Philips Healthcare to acknowledge receipt of the Field Safety Notice as soon as possible.

Device

IntelliVue patient monitors used with 12-lead ECG

Manufacturer

Philips Healthcare
  • Manufacturer Address
    Manufacturer contacts Philips Customer Care Service Centre Tel: 0870 532 9741claudia.romagnuolo@philips.com
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHRA