| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00974-1 |
| Product Name/Description |
Puritan Bennett 840 Ventilator
ARTG Number: 182309 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
This is a follow up to an earlier communication (TGA ref.: RC-2014-RN-00618-1), for which, if customers were impacted, would have received a visit from a Covidien representative to assess whether their Puritan Bennett 840 ventilator Power Supply Unit (PSU) required replacement. Some of the affected PSUs were replaced as part of the routine service of the Puritan Bennett 840 ventilators by Covidien outside of the previous corrective action.
The customer reports that initiated these changes to the Operator’s Manual included the graphical user interface (GUI) display screens (both upper and lower) becoming blank or erratic during patient 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 requesting the user to update the Puritan Bennett 840 Ventilator Operator's Manual as per the updated instructions attached with the customer letter in addition to the hardware upgrade they may have received. This action has been closed-out on 18/03/2016. |
| Contact Information |
1800 350 702 - Covidien Technical Services Team |