| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01088-1 |
| Product Name/Description |
Puritan Bennett 980 Series Ventilator System
ARTG: 221416 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Normally, if the ventilator is in use and both oxygen and air gas sources are disconnected (leaving the ventilator with no supply of compressed air or oxygen for ventilation of the patient), the ventilator annunciates a high priority “No Air Supply” and “No O2 Supply” alarm. The ventilator then enters a “Safety Valve Open” condition. Usually this is immediately recoverable when a gas supply source is reconnected. However, due to a software issue, in some cases the ventilator may transition with a “Ventilator Inoperative” condition upon reconnection of a gas supply source. During a “Ventilator Inoperative” condition, the patient is not provided ventilatory support, but may breathe room air spontaneously through the open safety valve. Covidien has had no reports of serious patient injury or death associated with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Covidien representative will update the software on affected ventilators as soon as possible. Customers may continue to use the ventilators during this time pending the software correction as long as two gas sources are connected to the ventilator at all times. Covidien is also providing important safety reminders in the customer letter which is described in the Puritan Bennett 980 ventilator operator’s manual. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 350 702 - Covidien Technical Services Team |