BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON CANISTER

    MDR report key: 18231552 · Received November 29, 2023

    Report

    Report Number
    3011157718-2023-00246
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    October 10, 2023
    Report Date
    April 23, 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
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE LOG FILES WERE NOT AVAILABLE FOR EVALUATION. H3 OTHER TEXT : LOG FILES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    PER LYNDA MOON RN AT THE ACCOUNT, THE GAUSS DEVICE SHOWED OVERSATURATION DURING A PROCEDURE. WHEN THE OVERSATURATION MESSAGE WAS PRESENTED BY THE DEVICE, THE CUSTOMER DISCONTINUED USE AND REVERTED BACK TO MANUALLY ESTIMATION BLOOD LOSS WITHOUT THE USE OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    PER (B)(6) RN AT THE ACCOUNT, THE GAUSS DEVICE SHOWED OVERSATURATION DURING A PROCEDURE. WHEN THE OVERSATURATION MESSAGE WAS PRESENTED BY THE DEVICE, THE CUSTOMER DISCONTINUED USE AND REVERTED BACK TO MANUALLY ESTIMATION BLOOD LOSS WITHOUT THE USE OF THE DEVICE. 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
    1845978 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