Events

Safety Alert Or Field Safety Notices for Medical oxygen and medical air cylinders filled to 200 atmospheres (200 bar/20,000 kPa)

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 manufacturer #17429.

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/2013/002
  • Event Number
    CON224427
  • Event Date Posted
    2013-01-14
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON224427?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
    Risk of serious injury to staff and patients. currently 137 bar cylinders are widely used in the uk. connection to significantly higher pressure 200 bar cylinders may cause damage to devices such as anaesthetic machines, ventilators, incubators, respiratory support and resuscitation equipment. a hospital trust is undertaking a pilot scheme to introduce 200 bar cylinders into clinical use. while the trust involved has ensured the safety of these cylinders within their organisation, there are concerns that these cylinders could be moved out of the trust during patient discharge, or patient transfer in ambulances for use with transport incubators and transport ventilators.
  • Action
    Be aware that 200 bar medical oxygen and medical air cylinders will be entering clinical use in a pilot scheme.  If this pilot is successful, the use of 200 bar cylinders is expected to become widespread across the UK. Before connecting these 200 bar cylinders to medical devices staff must confirm that it is safe to operate at this higher pressure by checking the instructions for use, or contacting the manufacturer. All users should check the cylinder label before use to ensure the cylinder gas and pressure are appropriate and that the expiry date has not been exceeded. Staff must seek permission to remove cylinders for use outside the hospital and ensure the above checks are carried out prior to use.

Device

Medical oxygen and medical air cylinders filled to 200 atmospheres (200 bar/20,000 kPa)
  • Model / Serial
  • Product Description
    Medical oxygen and medical air cylinders filled to 200 atmospheres (200 bar/20,000 kPa). Various sizes and outlets. Supplied by SOL SpA. Medical oxygen at 200 bar with pin index valve in 2, 5 and 50 litre capacity cylinders. Medical oxygen at 200 bar with bull nose valve in 10 and 20 litre capacity cylinders. Medical air at 200 bar with pin index valve in 2, 5, 10, 20 and 50 litre capacity cylinders.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429