BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON CANISTER

    MDR report key: 16632523 · Received March 28, 2023

    Report

    Report Number
    3011157718-2023-00030
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    September 9, 2019
    Report Date
    March 28, 2023
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PBZ
    PMA / PMN Number
    K142801
    Removal / Correction Number
    Z-1186-2023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PER THE CUSTOMER, THE OB PROVIDER WAS ¿OVERREACTING¿ TO ACTIVE BLEEDING BECAUSE THE TRITON QBL SYSTEM WAS REPORTING AN ACCEPTABLE QBL. 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
    1650702 TRITON CANISTER IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS PBZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown