BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4558GSP- GREENLIGHT FIBER OPTIC LARYNGOSCOPE HANDLE

    MDR report key: 9787049 · Received March 4, 2020

    Report

    Report Number
    8030673-2020-00088
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    October 24, 2019
    Report Date
    October 30, 2019
    Manufacturer
    VYAIRE MEDICAL.
    Product Code
    CCW
    UDI-DI
    55885403271739
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE VYAIRE MEDICAL CONDUCTED A FAILURE INVESTIGATION AND DETERMINED THAT THERE IS NO ISSUES WERE FOUND WITH THE PRODUCT REPORTED BY THE CUSTOMER DUE TO INSTRUCTION FOR USE IN P/N 36-20919 STATES THAT THE PRODUCT IS EXCLUSIVE FOR USE WITH VITAL SIGNS SINGLE-PATIENT-USE FIBER OPTIC LARYNGOSCOPE BLADE, MANUFACTURED BY VITAL SIGNS, INC. AND THE PRODUCT IS NOT COMPATIBLE WITH ISO GREEN STANDARD BLADE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE APPLIED. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSTRUCTION FOR USE IN GREENLIGHT¿ FIBER OPTIC LARYNGOSCOPE HANDLE STATES THAT THIS IS NOT COMPATIBLE WITH ISO GREEN STANDARD BLADE. HOWEVER, THE CUSTOMER USED THE PRODUCT ON A PATIENT WHICH CAUSED A DELAY IN TREATMENT, BUT THE CUSTOMER ADVISED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250893 4558GSP- GREENLIGHT FIBER OPTIC LARYNGOSCOPE HANDLE LARYNGOSCOPE, RIGID CCW VYAIRE MEDICAL. 4558GSP- GREENLIGHT¿ FIBER OPTIC LARYNGOSCOPE HANDLE 55885403271739

    Patients

    Seq Age Sex Outcome Treatment
    1