October 2021 : Field Safety Notice AX067/21/S : Missing regular reboot of the system may result in frozen vital signs
Field Safety Notice AX067/21/S : Missing regular reboot of the system may result in frozen vital signs
Affected Medical Device :
Sensis
Sensis Vibe Combo
Sensis Vibe Hemo
MDA Reference Number : MDA/FCA/2021-P140
MDA Registration Number :
GC58192270417
GC26491801918
Decription :
The system operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances this may result in a partly freeze of the user interface which would no longer update the vital signs.
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]
