Device product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Z-2350-2021
Product summary
- 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
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