BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    TRITON AI SOFTWARE

    MDR report key: 23399818 · Received October 28, 2025

    Report

    Report Number
    3015967359-2025-99408
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Report Date
    January 27, 2026
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PBZ
    UDI-DI
    07613327622768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS): 1 DEVICE: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED. ADDITIONAL INFORMATION: 1 DEVICE WAS NOT LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99408. SUPPLEMENTAL RATIONALE. CORRECTED DATA: B5, H6, H11. 1 PREVIOUSLY REPORTED EVENT WAS INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. EVALUATION FINDINGS (RESULTS/COMPONENTS) 1 DEVICE: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION 1 DEVICE: PRODUCT NOT RECEIVED.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: HIGH READINGS. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    NO CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428634 TRITON AI SOFTWARE IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS PBZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 07613327622768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown