| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00676-1 |
| Product Name/Description |
NeoMode software used on Puritan Bennett 980 Series (PB980) Universal Ventilator System
ARTG Number: 221416 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
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 recognised. There have been no serious injuries or deaths related to these reports. Covidien’s investigation has identified a software anomaly that contributes to this volume delivery issue in neonatal VC+ mode. This issue has not been observed during neonatal pressure control ventilation, or with paediatric or adult modes of ventilation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Covidien will develop and implement a software update for the universal models of ventilators with NeoMode capability. Until that time, Covidien will disable the clinician’s ability to use NeoMode in the PB980 ventilator. A service engineer will be in contact with hospitals to coordinate this process.
This action has been closed out on 24/10/2018 |
| Contact Information |
1800 350 702 - Technical Support Department |