Device product
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
Z-1184-2023
Product summary
- Event
- Event 91578
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 101 units
- Official record key
device-enforcement:Z-1184-2023
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: 10859506006125 Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001
Distribution pattern: US Nationwide distribution.
Derived failure modes
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Device software or design
Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can