Ogos 2021 : Corrective action reporting for FMI 34120 : Flow Sensors with Potentially Damaged Tubesin GEHealthcare/ Datex-Ohmeda Anesthesia Machines.
Corrective action reporting for FMI 34120 : Flow Sensors with Potentially Damaged Tubesin GEHealthcare/ Datex-Ohmeda Anesthesia Machines.
Affected Medical Device : Flow sensors that can be used on Aisys CS2, Avance CS2, Aisys, Avance, Amingo, Aespire View, Aespire 7900, Aespire 7100/100, Aestiva MRI, Aestiva 7900, Aestiva 7100, 9100C NXT, Aelite NXT, Protiva 7100
MDA Reference Number : MDA/FCA/2021-P118
MDA Registration Number :
GC59982267817
GC72098321117
GC56243638018
GC59798719918
Decription : GE Healthcare (GEHC) internally identified that a small number of flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts. This issue could cause leaks resulting in incorrect anesthesia machine tidal volumes, potentially leading to over-delivery of volume to the patient.
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]
