BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 8185131 · Received December 20, 2018

    Report

    Report Number
    0001811755-2018-02860
    Event Type
    Death
    Date Received
    December 20, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 20, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JCX
    UDI-DI
    07613154522309
    PMA / PMN Number
    K132671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGED DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING AN OPEN ABDOMEN PROCEDURE, A PATIENT EXPERIENCED CARDIOPULMONARY ARREST. PER THE CUSTOMER, AT THE TIME, THE NEPTUNE WAS USED AS A "WOUND VAC" (VACUUM ASSISTED CLOSURE) IN THE PROCEDURE, THE PATIENT NO LONGER SHOWED VITAL SIGNS. THE CUSTOMER FURTHER REPORTED THAT A CUSTOMER EMPLOYEE ATTEMPTED TO USE THE NEPTUNE DEVICE TO CREATE A "WOUND VAC" TO THE AREA WHERE BLEEDING WAS PROFUSE. THE PATIENT WAS REPORTED TO HAVE DIED DURING THE PROCEDURE. PER THE ORIGINAL REPORTER FROM THE CUSTOMER, THE NEPTUNE IN NO WAY CAUSED OR CONTRIBUTED TO THE DEMISE OF THE PATIENT. WHILE IT WAS REPORTED THAT THE NEPTUNE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S CONDITION PER THE ORIGINAL REPORTER, USING THE NEPTUNE IN CONJUNCTION WITH CLOSED WOUND DRAINS IS A CONTRAINDICATION OR USAGE AND COULD RESULT IN A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024729 NEPTUNE 2 ROVER ULTRA (120V) APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX STRYKER INSTRUMENTS-KALAMAZOO 07613154522309

    Patients

    Seq Age Sex Outcome Treatment
    1 Death