Julai 2021 : FSCA Notice SCA-21-001 - Fabian Ventilator : Power Board Failures due to Component Electrical Overstress

FSCA Notice SCA-21-001 - Fabian Ventilator : Power Board Failures due to Component Electrical Overstress

Affected Medical Device : Fabian Neonatal / Pediatric Ventilators

MDA Reference Number : MDA/FCA/2021-P101

MDA Registration Number : GC92488887018

Decription : Failure of the Power Board for affected fabian Therapy evolution, fabian +nCPAP evolution and fabian HFO ventilators

Local Establishment Contact Detail :

Salasiah
Schmidt BioMedTech Sdn Bhd
5th Floor Wisma Tecna, 18A Jalan 51A/223, 46100 Petaling Jaya, Selangor
03 7844 9000