BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON CANISTER

    MDR report key: 18104432 · Received November 9, 2023

    Report

    Report Number
    3011157718-2023-00245
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    October 13, 2023
    Report Date
    March 19, 2024
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PBZ
    PMA / PMN Number
    K163507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: H3, H6. DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE EVALUATION.

    Description of Event or Problem · 0

    PER THE CUSTOMER, THE DEVICE DISPLAYED LOWER THAN EXPECTED QBL READINGS 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 CUSTOMER, THE DEVICE DISPLAYED LOWER THAN EXPECTED QBL READINGS 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
    103548 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 NA Unknown