Notification on Initial Report for 2021-CC-SRC-007 (2021-07-A) - Trilogy EV300, Trilogy Evo and Trilogy Evo O2 Software Issue

 

Affected Medical Device : 

Trilogy Evo O2
Trilogy EV300

 

MDA Reference Number : MDA/FCA/2021-P113

 

MDA Registration Number : 

GC2627520-39891
GC5498920-50666

 

Decription : Two (2) separate software issues impacting baseline pressure for referenced devices.

 

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.