BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HANDLE

    MDR report key: 1915438 · Received November 4, 2010

    Report

    Report Number
    1718887-2010-00001
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 6, 2010
    Report Date
    November 4, 2010
    Manufacturer
    VITAL SIGNS COLORADO, INC.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REDESIGNED GREENLIGHT II HANDLE OF THE GREENLIGHT LARYNGOSCOPE SYSTEM LEAVES THE BATTERY UNSUPPORTED AT THE TOP OF THE MODULE. AT REST, THE POSITIVE TERMINAL ON THE UPPER BATTERY IS HELD IN PLACE BY THE BATTERY INSERT HOUSING. IF THE HANDLE IS SUBJECTED TO FORCE PERPENDICULAR TO THE LONG AXIS OF THE HANDLE, THE AA BATTERY CAN SHIFT SO THAT THE POSITIVE POLE OF THE TOPMOST BATTERY SLIPS OUT OF THE HOLE AND CANNOT MAKE CONTACT WITH THE PRESSURE SWITCHED LIGHT. THE ISSUE IS SPECIFIC TO THE CURRENT REVISION RELEASED ON (B)(6) 2010 AND WOULD NOT OCCUR ON PREVIOUSLY RELEASED REVISIONS. THE PRODUCT WAS PLACED ON HOLD ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREENLIGHT LARYNGOSCOPE HANDLE DID NOT ILLUMINATE WHEN AN EMERGENCY MEDICAL TECH REMOVED THE HANDLE FROM THE BAG FOR USE ON A PATIENT. THE EMT REMOVED A BACKUP HANDLE FROM THE BAG AND THE SAME ISSUE OCCURRED. THE EMT REMOVED THE BATTERY CARTRIDGE FROM THE HANDLE AND NOTED THAT THE BATTERY WAS NOT PROPERLY SEATED IN THE CARTRIDGE. THE EMT REPORTEDLY REINSERTED THE BATTERY AND THE HANDLE FUNCTIONED PROPERLY. THE REPORTER INDICATED THAT THIS TOOK APPROX 60 SECONDS. NO ADVERSE PT OUTCOME RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HANDLE LARYNGOSCOPE HANDLE CCW VITAL SIGNS COLORADO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1