Field Safety Notice FSN_HAM-C3 : HAMILTON-C3 ventilator software version 2.0.8, Block Protocol feature

 

 

Affected Medical Device : HAMILTON-C3 ventilator

 

MDA Reference Number : MDA/FCA/2021-P146

 

MDA Registration Number : GC25545945118

 

Decription :

a software issue related to the Block Protocol feature which can be optionally turned on during the configuration sequence allowing the ventilator to connect via a RS-232 interface to a patient monitor, a patient data management system (PDMS), or another computer system.

 

Local Establishment Contact Detail :

Nur Diana Abd Razak
Head of Quality Assurance
No. 43, Jalan Tiara Sentral 2, Nilai Utama Enterprise Park, 71800 Nilai, Malaysia

Email : [email protected]

 A copy of FSN.