November 2021 : Customer Safety Information (CSI) for Field Safety Corrective Action FCA AX077/21/S | FSN AX078/21/S, AX081/21/S : ComboBox does no longer login automatically after several reboots. Calculation of Cardiac Output (Thermodilution method) on
Customer Safety Information (CSI) for Field Safety Corrective Action FCA AX077/21/S | FSN AX078/21/S, AX081/21/S : ComboBox does no longer login automatically after several reboots. Calculation of Cardiac Output (Thermodilution method) on Hemodynamic intelligent Signal Input Box (HiSIB) might become blocked
Affected Medical Device : Sensis Vibe Combo, Sensis Vibe Hemo
MDA Reference Number : MDA/FCA/2021-P177
MDA Registration Number : GC26491801918
Description :
A potential issue with Sensis Vibe Combo system currently with VD12A software and a corrective action that will be performed.
Local Establishment Contact Detail :
Nur Ayuni Abas
Siemens Healthcare Sdn. Bhd.
SHS AP ASN MAS QT
Level 16, CP Tower,No. 11, Jalan 16/11,Pusat Dagang Seksyen 16,46350 Petaling Jaya, Selangor, Malaysia
Tel.: +60 3 7952-5236
Fax: +60 3 7955-7331
Email : [email protected]
