| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01326-1 |
| Product Name/Description |
Puritan Bennett 980 Series Ventilator System
ARTG number: 221416 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Following an investigation initiated by customer complaints, a capacitor in the screen of the device has failed and this has on some cases been accompanied by a burning odour, smoke or visible haze emanating from the display. This has caused the display to dim (reduced illumination) or go blank (loss of illumination), and has in some cases prompted the caregiver to transfer the patient to an alternate ventilator.
In all cases the ventilator continued to provide ventilatory support to the patient when this has occurred. No reports of fire, serious patient injury or death associated with this issue have been received and an engineering assessment and external consultant evaluation, have determined that future occurrences, if any, of this capacitor failure would present a low probability for a fire to propagate within or outside the display enclosure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Covidien will update all affected ventilators to LED illumination display, which does not utilise a backlight inverter (BLI) and thereby completely eliminate any future potential for this component failure. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 350 702 - Covidien Technical Support Department |