BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON CANISTER

    MDR report key: 20095515 · Received August 29, 2024

    Report

    Report Number
    3015967359-2024-01746
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 30, 2024
    Report Date
    February 11, 2025
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PBZ
    UDI-DI
    00859506006029
    PMA / PMN Number
    K163507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. UPDATE: D4, CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE CORRECT GTIN FORMAT

    Description of Event or Problem · 0

    PER THE ACCOUNT, THE TRITON CANISTER SOFTWARE GAVE A LOW ESTIMATED BLOOD LOSS READING DURING A PROCEDURE. 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 CANISTER SOFTWARE GAVE A LOW ESTIMATED BLOOD LOSS READING DURING A PROCEDURE. 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
    1355452 TRITON CANISTER IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS PBZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 00859506006029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown