Events

Safety Alert Or Field Safety Notices for Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0

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 Draeger.

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
  • Date
    2018-05-02
  • Event Date Posted
    2018-05-02
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/infinity-acute-care-system-and-m540-patient-monitors-software-versions-vg2-2-vg6-0-risk-that-alarms-are-not-activated
  • 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
    Under certain circumstances the device can be accurately displaying invasive blood pressure measurements on the patient monitor and central display but have no active audible or visual alarms to alert users when these measurements are abnormal because of a software problem.
  • Reason
    Manufactured by draeger – a software issue may prevent the activation of audible and visual invasive blood pressure measurement alarms, risking a delay to treatment.
  • Action
    Identify any affected devices in your organisation. Follow the instructions in the Field Safety Notice issued by Draeger to avoid blood pressure alarms being inadvertently deactivated. If you possess affected devices, return the response form included on the FSN to Draeger.

Device

Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0
  • Model / Serial
  • Manufacturer
    Draeger

Manufacturer

Draeger
  • Manufacturer Address
    Draeger Medical UK Ltd Helen GlassTel: 01442 213542 Email: helen.glass@draeger.com
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    MHRA