Corrective action reporting for FMI 34122 : Carestation 750/750c Anesthesia Delivery Systems - After a specific sequence of actions, audible tone of "O2 supply pressure low" alarm will remain silenced until system reboot.

 

 

Affected Medical Device : Carestation 750/750c Anesthesia Delivery Systems

 

MDA Reference Number : MDA/FCA/2021-P166

 

MDA Registration Number : GC2333221-51495

 

Description : 

Carestation 750/750c anesthesia delivery systems have a software defect related to the “O2 supply pressure low” high priority alarm.

 

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.