| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00093-1 |
| Product Name/Description |
Puritan Bennett 840 Ventilator and 700 Series (740 and 760) Ventilators
Oxygen Sensor Part Number for 840 Ventilator: 4-072214-00
Oxygen Sensor Part Number for 700 Series Ventilator: G-062010-00
ARTG Number: 182309 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
The oxygen sensor for the ventilators has a life of one (1) year from date of manufacture of the sensor, depending on the operating conditions. Conflicting information was provided to Puritan Bennett 840 ventilator customers in a labelling addendum stating that the oxygen sensor should be replaced every two years. If a sensor becomes non-functional during use and cannot be recalibrated, an external oxygen monitoring device with oxygen alarm capability may be required to monitor the supplied level of oxygen from the ventilator and to provide appropriate alarms. A non-functional O2 sensor does not affect the concentration of oxygen delivered from the ventilator and does not control the flow of gases. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Covidien is providing updated labelling to clarify the operational life of the oxygen sensor used in the Puritan Bennett 840 and 700 series ventilators. Coviden is also advising users that if a sensor becomes non-functional and facility protocol requires transfer of a patient to an alternate ventilator, the patient must be clinically evaluated to determine the best conditions for transfer to reduce risk to the patient. |
| Contact Information |
1800 350 702 - Covidien Technical Services Team |