BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON AI

    MDR report key: 19191847 · Received April 26, 2024

    Report

    Report Number
    3011157718-2024-00001
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 1, 2024
    Report Date
    November 12, 2024
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PBZ
    UDI-DI
    07613327623192
    PMA / PMN Number
    K163507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: D9, H3, H6. CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE FULL UDI NUMBER IS NOT AVAILABLE DUE TO THE MISSING LOT NUMBER.

    Description of Event or Problem · 0

    PER THE ACCOUNT, THE TRITON SOFTWARE FLASHES THE INCORRECT BLOOD AMOUNT AND THEN CORRECTS ITSELF, WHICH COULD LEAD TO AN INACCURATE MEASUREMENT OF BLOOD LOSS. THE DEVICE SHOWED 1429 ML OF BIOMATTER WHICH WAS LOWER THAN THE ACTUAL AMOUNT COLLECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    PER THE ACCOUNT, THE TRITON SOFTWARE FLASHES THE INCORRECT BLOOD AMOUNT AND THEN CORRECTS ITSELF, WHICH COULD LEAD TO AN INACCURATE MEASUREMENT OF BLOOD LOSS. THE DEVICE SHOWED 1429 ML OF BIOMATTER WHICH WAS LOWER THAN THE ACTUAL AMOUNT COLLECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038942 TRITON AI IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS PBZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 07613327623192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown