Corrective action reporting for FMI 34118 : URGENT MEDICAL DEVICE CORRECTION - Turbine Over temperature alarm/failure,a buildup of PEEP higher than set values, and Plateau Pressure inaccuracy could occur on Siaretron 4000T and Falco 202 Evo Ventilators (touch screen versions)

 

Affected Medical Device : Siaretron 4000T and Falco 202 Evo Ventilators (touchscreen versions) with 1.8.13 software

 

MDA Reference Number : MDA/FCA/2021-P082

 

MDA Registration Number : GC659131016718, GC61614558318

 

Decription : Turbine over temperature, PEEP buildup above the set value, and plateau pressure reading inaccuracy could occur when using the ventilator in certain conditions.

 

Local Establishment Contact Detail :

Benedict Lee
ASEAN Regulatory Affairs Specialist
GE Healthcare Sdn Bhd
Level 6, 1 Sentral, Jln Travers, KL Sentral, 50470 KL
03 22739788

Email : benedict.lee@ge.com

 A copy of FSN.