Important Safety Notice VISTA 120 CMS SpO2 Alarm : Software Patch for Vista CMS required

 

 

Affected Medical Device : Vista 120 and Central Monitoring Station (CMS) using CMS SW1.64

 

MDA Reference Number : MDA/FCA/2021-P130

 

MDA Registration Number : GC3840819-37203

 

Decription : Draeger has become aware of an event during which an exceeding of SpO2 alarm thresholds triggered an alarm at the bedside monitor Vista 120 as expected but that this did not lead to visual or audible alarming at the Central Monitoring Station (CMS). Numeric values were displayed correctly.

 

Local Establishment Contact Detail :

Beatrice Mah
QRA Specialist
Quality and Regulatory Affair Division
Draeger Malaysia Sdn. Bhd.
No. 6, Jalan 15/22,Taman Perindustrian Tiong Nam,Seksyen 15, 40200 Shah Alam,Selangor Darul Ehsan, Malaysia.
DL: +603 5526 2043
Tel: +603 5526 2000

Email : beatrice.mah@draeger.com

 

 A copy of FSN.