November 2021 : 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.
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 : [email protected]
