Device product
Draeger Infinity Acute Care System Monitoring Solution
Z-0714-2014
Product summary
- Event
- Event 67056
- Status
- Terminated
- Classification
- Class II
- Quantity
- 439
- Official record key
device-enforcement:Z-0714-2014
Official wording
Reason: After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
Code information: with software versions VG2.0.3 and higher.
Distribution pattern: US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
Derived failure modes
-
Unknown
After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.