Corrective action reporting for FMI 36149 : CARESCAPE PDM – Masimo SpO2 Saturation Values can become frozen after an extended length of usewithout a power down.

 

Affected Medical Device : CARESCAPE PDM 2042084-001

 

MDA Reference Number : MDA/FCA/2021-P085

 

MDA Registration Number : GC58636720018

 

Decription : Masimo SpO2 Saturation Values can become frozen after an extended length of usewithout a power down.

 

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 : benedict.lee@ge.com

 A copy of FSN.