Philips Healthcare provided the following statement in response to RT’s recent article, “Philips V60, V60 Plus HFO-equipped Ventilators Recalled Over Risk of Reduced Oxygen.”
As reported, in June, Philips contacted customers regarding an identified issue affecting all V60 Plus ventilators and all V60 ventilators upgraded to enable High Flow Therapy (software version 3.00 and 3.10), which may occur under certain circumstances.
Affected Philips V60 Plus ventilators and 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 mode. If the system pressure reaches the maximum limit, the ventilator will sound the “Cannot Reach Target Flow” (CRTF) alarm and will reduce the pressure, which will simultaneously decrease the flow rate.
Should this occur, in cases where flow rate decreases due to device reaching the maximum pressure, patients may experience impacts needing escalation in medical treatment. To date, Philips has received a limited number of reports of this issue occurring, with some cases involving a degree of hypoxemia in affected patients.
Affected systems are not required to be removed from service, and may continue to be used consistent with the device Instructions for Use, and the customer safety letter, which provides guidance on this matter.
An addendum to the Instructions for Use will be attached to the customer safety letter and included with new V60 Plus Ventilators shipped with version 3.00 or 3.10 software and HFT enabled, and the V60 HFT Field Upgrade Kit. This user manual addendum provides additional technical details about the CRTF alarm functionality.
Philips also anticipates releasing a technical correction for this matter, and will notify customers when it is available.
If customers need further information or support concerning this customer safety letter, they may contact their local Philips representative or call +1-800-722-9377.
Philips is committed to addressing this issue quickly and efficiently, to meet our commitments to our customers and their patients who rely on our respiratory care solutions.
