Jun 2021 : Corrective action reporting for FMI 36149 : CARESCAPE PDM – Masimo SpO2 Saturation Values can become frozen after an extended length of usewithout a power down.
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 : [email protected]
