Events

Recall of Astral 100 and Astral150 Ventilators - Degraded Battery Pack

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Resmed Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01074-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01074-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Resmed has received a small number of reports regarding the performance of the internal battery in the astral ventilator. in these reports, an internal electrical issue has led to ventilation ceasing without either the low battery alarm or the critically low battery alarm being activated. in all of these reported cases the “total power failure” alarm activated as intended.Under these circumstances, ventilator dependent patients may be at risk if no urgent action is taken to restore power or switch to back-up ventilation. the risk of this occurring is increased if the internal battery has been charged a high number of times. this fault has also been reported with the astral external battery however, there have been no reports of cessation of ventilation when the astral external battery is used.It remains safe to continue using astral ventilators, provided patients/carers follow the precautions provided. there have been no reports of adverse health effects as a result of this issue.
  • Action
    ResMed is providing users with work around instructions to follow as an interim measure. Patients and carers are advised to connect the ventilator to AC power whenever possible, and to use an external power supply where necessary. It is recommended that ventilator dependant patients have alternative ventilation equipment available at all times. All ventilators with an affected battery pack should have their internal batteries replaced by no later than 1 December 2016. For further information, please see https://www.tga.gov.au/alert/astral-100-and-astral-150-ventilators-0

Device

Astral 100 and Astral150 Ventilators - Degraded Battery Pack
  • Model / Serial
    Astral 100 and Astral150 Ventilators - Degraded Battery Pack Serial Numbers below: 22161332346 for Astral ventilators, and 20160748193 for Astral external batteriesARTG Numbers: 219429, 158756
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited