| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00653-1 |
| Product Name/Description |
Puritan Bennett 840 Ventilator with 9.4 inch graphical user interface (GUI) assembly
ARTG Number: 182309 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
Covidien has received customer reports that have included the GUI display screens (both upper and lower) becoming blank during use. This event interferes with the clinician’s ability to view and/or change ventilator setting or clinician-set patient alarm parameters. The ventilator continues to provide respiratory support during these events. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Covidien is advising that if users encounter a loss of display, they are advised to verify the patient’s respiratory and physiological stability ie, confirm the patient is receiving ventilatory support by observation of the expansion and contraction of the patient’s chest and assess current patient status by review of other monitoring (e.g., oxygen saturation, heart rate, blood pressure, etc). The patient should be transferred to an alternative ventilator.
Covidien will be replacing affected backlight inverter PCBAs and performing 10,000 hour preventative maintenance. This action has been closed-out on 29/01/2016. |
| Contact Information |
1800 350 702 - Covidien Technical Services |