Events

Safety Alert Or Field Safety Notices for V60 ventilator

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 Respironics.

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
    2017-05-17
  • Event Date Posted
    2017-05-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/v60-ventilator-potential-for-unexpected-shutdown
  • 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 respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown.
  • Action
    Identify all devices with software version 2.20 (which may have been upgraded by some customers between 17 April 2016 and 4 January 2017) as per Philips’s FSN 86600036A. Ensure either hospital biomedical engineers or Philips field service engineers install the correct software (version 2.10). Philips advise in their FSN that devices with software version 2.20 should not be used unless close clinical observation is available. If alternative devices are unavailable, carry out an individual risk assessment for the continued use of the devices with version 2.20 software until version 2.10 can be installed. Contact Philips Respironics to acknowledge receipt of the FSN.

Device

V60 ventilator

Manufacturer

Philips Respironics
  • Manufacturer Address
    Mr Michael Turvey Q&R Officer Philips Health Systems Telephone: 0870 532 9741Email: michael.turvey@philips.com
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHRA