Device product
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Z-1186-2023
Product summary
- Event
- Event 91578
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 88 units
- Official record key
device-enforcement:Z-1186-2023
Official wording
Reason: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Code information: UDI-DI: 00859506006029 Software Version: 2.8.4
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Device software or design
Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can