Device product
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Z-1492-2025
Product summary
- Event
- Event 96331
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 37 units
- Official record key
device-enforcement:Z-1492-2025
Official wording
Reason: During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
Code information: UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
Distribution pattern: US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Derived failure modes
-
Unknown
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.