BEUDAMED
    FDA Adverse Event Death Summary report: N

    GREENLIGHT II HANDLES

    MDR report key: 2977890 · Received February 21, 2013

    Report

    Report Number
    1718887-2013-00001
    Event Type
    Death
    Date Received
    February 21, 2013
    Date of Event
    September 6, 2012
    Report Date
    January 22, 2013
    Manufacturer
    VITAL SIGNS COLORADO, INC.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION CURRENTLY AVAILABLE. NO LOT NUMBER INFORMATION CURRENTLY AVAILABLE. THE MANUFACTURE DATE THEREFORE IS UNKNOWN UNTIL THE LOT NUMBER IS PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LIGHT ON THE LARYNGOSCOPE BLADE DOES NOT WORK WHEN ATTACHED TO THE LARYNGOSCOPE HANDLE BECAUSE THE SPRING ON THE HANDLE WAS MISSING. AS A RESULT OF THE HANDLE NOT WORKING, IT WAS REPORTED THAT, "THE PATIENT WASN'T INTUBATED FAST ENOUGH." THERE WAS A DELAY OF AN UNSPECIFIED LENGTH OF TIME WHILE THE HANDLE WAS REPLACED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT REPORTEDLY WENT INTO A COMA AND LATER DIED. THE CUSTOMER NOTED IT IS UNKNOWN IF THE DELAY IN INTUBATION CONTRIBUTED TO COMA AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77165 GREENLIGHT II HANDLES LARYNGOSCOPE, RIGID CCW VITAL SIGNS COLORADO, INC. 4558GSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death