TRITON AI SOFTWARE
Received Apr 22, 2026
Report 3015967359-2026-99319 · MDR key 24954402
Device
Generic name
Image Processing Device For Estimation Of External Blood Loss
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0894000001
Product problems
- Low Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 2 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS): 1 DEVICE: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. 1 DEVICE: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 2 DEVICES: PRODUCT DISPOSITION IS NOT YET DETERMINED. ADDITIONAL INFORMATION: 2 DEVICES WERE NOT LABELED FOR SINGLE-USE. 2 DEVICES WERE NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: LOW READINGS. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.