| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01089-1 |
| Product Name/Description |
Puritan Bennett 980 Series Ventilator System
ARTG 221416 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
The issue is related to a capacitor failure in the backlight inverter printed circuit board assembly (PCBA) in the ventilator display that can cause a dimming of the display that may be accompanied by a burning odour. In complaints reported to date, the Puritan Bennett 980 ventilator remained functional and ventilatory support to the patient continued when this failure occurred. The PCBA must be replaced to preclude possible failure of the component. Covidien 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 replace the backlight inverter PCBA on affected ventilators as soon as possible. Ventilators may continue to be used during this time. |
| Contact Information |
1800 350 702 - Covidien Technical Services Team |