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 : NurSyahirahFatini@idsmed.com

 

 A copy of FSN.