Jun 2021 : 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 Ven
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 : [email protected]
