October 2021 : FMI 38008 : Safety issues in Centricity High Acuity Critical Care (CHA CC) and Centricity High Acuity Anesthesia (CHA A)
FMI 38008 : Safety issues in Centricity High Acuity Critical Care (CHA CC) and Centricity High Acuity Anesthesia (CHA A)
Affected Medical Device : Centricity High Acuity Anesthesia and Centricity High Acuity Critical Care
MDA Reference Number : MDA/FCA/2021-P152
MDA Registration Number :
GMD17215498118A
GMD29146275517A
Decription :
#1. Incorrect infusion total volume displayed when restarting device connection after pump occlusion
#2. Incorrect cumulative output balance displayed in second Perioperative Case within same Visit
#3. Incorrect Renal Replacement Therapy fluid balance displayed when Application Server service is restarted
#4. Incorrect Renal Replacement Therapy fluid balance displayed when device connection is restarted after driver variable configuration
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]
