December 2021 : FSN 0321 MCC/21/005/IU : Sevoflurane vaporizers for Flow Family Anesthesia systems - presence of a yellow substance in the vaporizer.
FSN 0321 MCC/21/005/IU : Sevoflurane vaporizers for Flow Family Anesthesia systems - presence of a yellow substance in the vaporizer.
Affected Medical Device :
Sevoflurane vaporizers for Flow Family Anesthesia systems
(Maquet Flow-I Anesthesia System)
MDA Reference Number : MDA/FCA/2021-P180
MDA Registration Number : GC25644700318
Description :
Maquet Critical Care has received eight complaints describing the presence of a yellow substance in the vaporizer.
Local Establishment Contact Detail :
Syahirah Fatini
Regulatory Executive
IDS Medical Systems (M) Sdn Bhd
No. 8, Jalan Pensyarah U1/28, Hicom Glenmarie Industrial Park,40150 Shah Alam, Selangor
03-5022 5313
Email : [email protected]
