Starting from 1 January 2022, safety alerts related to medical devices not listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning ResMed Pty Ltd Astral 100 and Astral 150 ventilators [Date of manufacture: Between 2013 and 2019; Reference numbers: 27083, 27081, 27003, 19600, 19653, 27082 and 27088; Multiple serial numbers].
According to the TGA, the manufacturer has identified an issue with the performance of the supercapacitor component of seven batches of the Astral 100 and 150 portable ventilators. This component powers the total power failure (TPF) audible alarm which alerts the carer or clinician when the ventilator experiences a total loss of power that results in a stop of ventilation. The problem with the component is that it degrades over time, which may cause the TPF alarm to sound for less than 2 minutes, or in some cases, to not sound at all. This component does not affect any other alarm functionality, including low and critically low battery alarms. This issue does not affect therapy delivery.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00744-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Sep 2023