Preliminary Report FCA 2104 : Automated Blood Coagulation Analyzer CS-1600 - CS-1600/1300 EMC (Electromagnetic Compatibility) compliance issue

 

Affected Medical Device : Automated Blood Coagulation Analyzer CS-1600 - CS-1600/1300

 

MDA Reference Number : MDA/FCA/2021-P104

 

MDA Registration Number : IVDA3828910416

 

Decription : An electromagnetic noise (45.8dB) exceeding that of international specification(40.0dB) was observed around 145MHz when the sample probe detects the liquid surface. The noise source is identified as the oscillation output from the operational amplifier mounted on the sample probe liquid detection board PCB No.20026

 

Local Establishment Contact Detail :

Janice Ho
Senior Regulatory Affairs Specialist
Sysmex (Malaysia) Sdn Bhd
11A & 15 Jalan PJS 7/21, Bandar Sunway, 47500 Subang Jaya, Selangor
Tel +60 (3) 5637 1788

Email : Ho.Janice@Sysmex.com.my

 

 A copy of FSN.