BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVOS

    MDR report key: 8647858 · Received May 28, 2019

    Report

    Report Number
    8020893-2019-00118
    Event Type
    Death
    Date Received
    May 28, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 28, 2019
    Manufacturer
    NEW MERVUE INDUSTRIAL PARK
    Product Code
    MUD
    UDI-DI
    20884521105901
    PMA / PMN Number
    K082327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A PATIENT CAME WITH AN AORTIC DISSECTION. THE BASELINE OF THE DEVICE WAS LEFT 72 AND RIGHT 57. THE SURGERY TOOK SEVERAL HOURS, THEY BROUGHT THE PATIENT TO THE ICU, BUT THE PATIENT DIED A FEW HOURS LATER. IT WAS ALSO INDICATED THAT BEFORE AND AFTER THE PROCEDURE, THE DEVICE DID WORK CORRECTLY. IT IS UNKNOWN AT THIS TIME IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441621 INVOS OXIMETER, TISSUE SATURATION MUD NEW MERVUE INDUSTRIAL PARK SAFB 20884521105901

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death