Events

Safety Alert Or Field Safety Notices for ConchaTherm Neptune heated humidifiers

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 Teleflex.

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 ID
    MDA/2012/068
  • Event Number
    CON185606
  • Date
    2012-09-25
  • Event Date Posted
    2012-09-25
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON185606?tabName=allTabs
  • 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
    Potential for failure of the speaker. if the speaker fails, no alarm will sound in the event of a device failure, which could cause a delay in patient treatment. the manufacturer published a field safety notice (fsn), in june 2012 to notify users and prompt them to take action.  the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon. although the speaker failure will result in no alarm sounding if there is a problem, the humidifier will continue to detect any abnormalities and take appropriate action.
  • Action
    Locate and identify all affected devices using the list of serial numbers in the manufacturer’s FSN. Check the speaker by following the instructions in the manufacturer’s FSN. Return the acknowledgement form to Teleflex. If faulty speakers are found, contact Teleflex immediately to request replacement speakers as a priority. For future use, be aware that if the humidifier makes neither an audible alert nor alarm as part of the self-check on startup, there may be a fault with the speaker.

Device

ConchaTherm Neptune heated humidifiers
  • Model / Serial
  • Product Description
    ConchaTherm Neptune heated humidifiers. Product codes: 425–00, 425–10 and 425–30. Specific serial numbers. This heated humidification system is designed to heat and humidify respiratory gases delivered to adult and paediatric patients.
  • Manufacturer
    Teleflex

Manufacturer

Teleflex