Events

Safety Alert Or Field Safety Notices for Lung ventilators

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 ResMed.

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
    2017-09-12
  • Event Date Posted
    2017-09-12
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/lung-ventilators-astral-100-100sc-and-150-potential-power-loss-due-to-faulty-battery
  • 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
    ResMed’s actions:alternative batteries have been developed. Affected batteries are not being recalled.
    batteries will be replaced within the 2-year maintenance period, prioritised according to need. Customers who are concerned about the clinical need of their patients should contact ResMed directly.
    updating the user and clinical guides to advise on the safe use of Astral ventilators when not on AC power.The internal battery is designed to deliver continuous power when the external power source is disrupted.
    It is not intended to serve as a primary power source.Although both internal and external batteries are potentially affected, using both at the same time reduces the risk of power loss as it is highly unlikely that both sets of batteries will fail at the same time.Manufacturer contactsResMed (UK) Ltd
    Tel: 01235 862 997 Option 3
    Email: astralbatterysupport@resmed.com
  • Reason
    Manufactured by resmed – if operated only by the internal battery and this fails, the patient will not be ventilated.
  • Action
    Identify affected ventilators. Have systems in place to ensure that: users, including patients and carers, understand the problem detailed in the manufacturer’s Field Safety Notice follow the manufacturer’s advice an external battery is connected if the ventilator is used as a mobile unit an additional external power source and backup source of ventilation is available at all times once available, the warning sticker is put on affected ventilators ventilators and external batteries are returned to a service centre for routine maintenance when prompted Return the Field Safety Notice acknowledgement form to ResMed.

Device

Lung ventilators
  • Model / Serial
  • Product Description
    All internal, external and spare batteries are potentially affected by this problem. The RPSII battery is not affected.
  • Manufacturer
    ResMed

Manufacturer

ResMed