Device product

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

Z-2350-2021

June 08, 2021

Class II

Product summary

Firm: Terumo Cardiovascular Systems Corporation
Event: Event 88350
Status: Terminated
Classification: Class II
Quantity: 1 unit OUS
Official record key: device-enforcement:Z-2350-2021

Official wording

Reason: intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

Code information: S/N: 01751 UDI: 00886799000588

Distribution pattern: International distribution in the country of Panama.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs