Initial Report for FCO86600059 - V60/V60 Plus Ventilator - Information Regarding High Flow Therapy Option

 

Affected Medical Device : V60/V60 Plus Ventilator

 

MDA Reference Number : MDA/FCA/2021-P090

 

MDA Registration Number : 

GC26388685318
GC5712719-34776

 

Decription : 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.

 

Local Establishment Contact Detail :

Zam Zarina Mat Ail
Quality & Regulatory Manager
Philips Health Systems Malaysia
Philips Malaysia Sdn. Bhd. Level 9, Menara Axis, No.2, Jalan 51A/223, 46100 Petaling Jaya, Selangor Darul Ehsan. MALAYSIA.

Email : zam.zarina@philips.com

 A copy of FSN.