TRITON AI SOFTWARE
Received Apr 15, 2025 · Event occurred Mar 24, 2025
Report 3015967359-2025-00627 · MDR key 21838696
Device
Generic name
Image Processing Device For Estimation Of External Blood Loss
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0894-000-001
Product problems
- Low Readings
- Low Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PER THE USER FACILITY, WHEN UPDATING THE PATIENT HEMOGLOBIN MID CASE, THE DEVICE SUBTRACTED APPROXIMATELY 1500ML OF BLOOD LOSS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
UPDATE: D9, H3, H6. CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE LOG FILES WERE NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem
NO NEW INFORMATION.