Ogos 2021 : Important Safety Notice Atlan A300, Atlan A300XLAtlan A350, Atlan A350XL : Artefacts on pressure and flow curve
Important Safety Notice Atlan A300, Atlan A300XLAtlan A350, Atlan A350XL : Artefacts on pressure and flow curve
Affected Medical Device : Atlan Anesthesia Workstation with SW 1.01
MDA Reference Number : MDA/FCA/2021-P129-2
MDA Registration Number : GC7299919-37202
Decription : Atlan Anesthesia Workstation with SW 1.01 has shown artefacts on the pressure and flow curves while the devices are being operated in one of the following ventilation modes:PC – CMV, PC – SIMV/PS, VC – CMV/Autoflow, VC –SIMV/Autoflow, VC – SIMV/PS/Autoflow, CPAP/PSV.
Local Establishment Contact Detail :
Beatrice Mah
QRA Specialist
Quality and Regulatory Affair Division
Draeger Malaysia Sdn. Bhd.
No. 6, Jalan 15/22,Taman Perindustrian Tiong Nam,Seksyen 15, 40200 Shah Alam,Selangor Darul Ehsan, Malaysia.
DL: +603 5526 2043
Tel: +603 5526 2000
Email : [email protected]
