BEUDAMED
    FDA Adverse Event Death Summary report: N

    GREENLIGHT II

    MDR report key: 1394187 · Received May 22, 2009

    Report

    Report Number
    1718887-2009-00001
    Event Type
    Death
    Date Received
    May 22, 2009
    Date of Event
    March 26, 2009
    Report Date
    May 22, 2009
    Manufacturer
    VITAL SIGNS COLORADO, INC.
    Product Code
    EQN
    PMA / PMN Number
    K850437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIRTEEN SAMPLES RETURNED FOR EVALUATION. THE REPORTED PROBLEM WAS VERIFIED IN EACH OF THE SAMPLES. EACH SAMPLE WAS EXAMINED UNDER MAGNIFICATION, WITH NO DAMAGE SEEN ON THE BATTERY CLIPS. THE RETURNED SAMPLES WERE TESTED FOR MATERIAL THICKNESS AND COMPARED TO 15 SAMPLES FROM CURRENT INVENTORY, ALL WERE FOUND TO BE WITHIN SPEC. BATTERY CLIPS FROM INVENTORY WERE USED TO DETERMINE THE FORCE REQUIRED TO BEND THE CLIPS TO THE HEIGHT OF THE RETURNED SAMPLES. TWO BATTERY CLIPS FROM INVENTORY WERE MEASURED AND FOUND TO BE OF CORRECT HEIGHT. IN ORDER TO BEND TO CLIP TO THE HEIGHT OF THE RETURNED SAMPLES, A FORCE OF 65-105 LBS WAS REQUIRED. ACCORDING TO THE CUSTOMER, THE HANDLES ARE STORED IN "TECH" BOXES IN THE AMBULANCE AND IN DIFFERENT POSITIONS DEPENDING ON THE CLINICIAN OR AMBULANCE DESIGN. THIS DEVICE IS TO BE USED FOR TRACHEAL TUBE INTUBATIONS DURING ANESTHESIA, INTENSIVE CARE, AND EMERGENCY MEDICAL AIRWAY MANAGEMENT. THE HANDLE CONSISTS OF A LED LIGHT POWERED BY 2 AA BATTERIES AND A HEAD THAT INCORPORATES A HOOK-ON FITTING THAT CONNECTS A DETACHABLE FIBER-ILLUMINATED BLADE. THE LED MODULE INCORPORATES AN ELECTRICAL CONTACT SO THAT WHEN THE BLADE IS ENGAGED TO THE HOOK-ON FITTING AND IN THE OPERATING POSITION, THE LED ILLUMINATES. THIS DEVICE IS TO BE TESTED PRIOR TO USE, PER THE INSTRUCTIONS FOR USE. IT SHOULD NOT BE USED IF IT IS NOT OPERATING PROPERLY AND THEREFORE, THE PT WOULD NOT SUFFER ANY SERIOUS INJURY OR DEATH. THE FORCE REQUIRED TO BEND TO BATTERY CLIPS IN "NORMAL" USE CANNOT BE EXPLAINED. THE CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR THIS DEFECT FOR FUTURE TREND ANALYSIS.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT THE LIGHT WOULD NOT STAY ON, IT WAS INTERMITTENT AND THEN LIGHT WOULD GO OFF. THEY TRIED 3 DIFFERENT BLADES WITH THE HANDLE AND ALL REACTED THE SAME WAY. UPON REVIEW OF THE HANDLE BY THE ACCOUNT, THEY FELT THE BATTERIES WERE LOOSE IN THE CARTRIDGE AND WERE NOT TOUCHING WITH THE METAL CONTACT. THE BATTERIES CAN BE REMOVED JUST BY TILTING THE CARTRIDGE IN ANY DIRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT II GREEN STANDAR LARYNGOSCOPE HANDLE EQN VITAL SIGNS COLORADO, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death