Events

Safety Alert Or Field Safety Notices for SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018

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.

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
    2018-09-19
  • Event Date Posted
    2018-09-19
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/suresigns-vs-vm-patient-monitors-and-viewing-stations-manufactured-before-may-2018-risk-of-batteries-overheating-or-igniting-mda-2018-031
  • 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
    Philips have received reports of their SureSigns monitors with lithium ion batteries overheating or igniting when exceeding their three-year service interval or reaching 300 charge-discharge cycles. The current labelling and instructions for use (IFU) do not provide full instructions on when to replace the batteries. As a result, Philips are issuing an updated IFU and software upgrade to provide system warnings in aid of managing the battery replacement cycle.
  • Reason
    Manufactured by philips – lithium ion batteries which have exceeded their specified replacement interval or number of charging cycles are at risk of overheating or igniting.
  • Action
    Identify all affected devices (see manufacturers’ Field Safety Notice (FSN)). Check whether the battery has exceeded its’ three-year replacement interval or has reached 300 charge-discharge cycles in line with the FSN. Refer to the Philips SureSigns VS & VM monitors and View station Service Guide for details on how to replace the battery if required. Contact Philips to order replacement batteries. Ensure that there are systems in place to routinely check battery life until the software update is made available (November 2018) and installed. Contact Philips to confirm receipt of their FSN using their response form. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018
  • Model / Serial
  • Product Description
    Images of SureSigns VS & VM patient monitors and Viewing stations
  • Manufacturer
    Philips

Manufacturer

Philips
  • Manufacturer Address
    Philips Customer Care Service Centre Telephone: 0870 532 9741Email: DeviceVigilanceUKI@Philips.com.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHRA