The Therapeutic Goods Administration (TGA) of Australia posted a medical device safety alert concerning the neonatal applications (NeoMode software) in Puritan Bennett 980 series (PB980) Universal ventilator system manufactured by Covidien.
PB980 universal model ventilator is designed for neonatal, paediatric and adult patients. According to the manufacturer, there have been reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
The manufacturer will develop and implement a software update for the universal models of ventilators with NeoMode capability.
For details, please refer to the following TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00676-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 July 2015