| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01430-1 |
| Product Name/Description |
Philips V60 and V60 Plus Ventilators
Software Version 3.00 or Software Version 3.10
ARTG 285664
(Philips Electronics Australia Ltd - Portable ventilator, electric) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/06/2021 |
| Responsible Entity |
|
| Reason/Issue |
Philips advises that the V60/V60 Plus ventilators equipped with High Flow Therapy option (Software Version 3.00 and Software Version 3.10) are designed with a safety mechanism to limit the amount of pressure that can be delivered to the patient when the ventilator is operating in High Flow Therapy. In situations where the high flow therapy pressure reaches the maximum limit, the ventilator will sound a low priority, “Cannot Reach Target Flow (CRTF)” alarm and reduces the pressure – which also simultaneously decreases the flow rate to a level below what was set by the clinician for as long as the condition persists.
In some cases, patients may experience oxygen desaturation as a result of the decrease in flow rate, including moderate or severe hypoxemia. To date, there have been 25 serious injuries and zero (0) deaths worldwide associated with this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to be aware of the potential High Flow Therapy issues described in the customer letter (supplied to impacted facilities by the sponsor) and how to address them.
While using a High Flow Nasal Cannula, potential factors that could contribute but not limited to reaching the maximum high flow therapy pressure limit are: 1. compression of the cannula, 2. kinks in the tubing, 3. mucus plug blocking the flow, 4. patient movement, 5. positioning, 6. coughing, 7. blockage in the gas pathway, 8. and the inappropriate size of the nasal cannula for the flow setting.
The user manual addendum attached to the customer letter will be included with new V60 Plus Ventilators, V60 ventilator HFT Field Upgrade Kits, and is also available on the Philips website at www.philips.com/hrcmanuals
Philips is developing a technical correction and will notify customers when the correction is available. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |