BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRATORY SUPPORT PRODUCTS, INC.

    MDR report key: 70661 · Received February 14, 1997

    Report

    Report Number
    70661
    Event Type
    Death
    Date Received
    February 14, 1997
    Date of Event
    January 25, 1997
    Report Date
    January 27, 1997
    Manufacturer
    SMITH INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    EQN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PARAMEDICS EXPERIENCED EQUIPMENT FAILURE WITH LARYNGOSCOPE HANDLE WHEREBY LIGHTING WENT OUT EVERY TIME ANY PRESSURE WAS APPLIED WHILE TRYING TO INTUBATE INFANT WITH SUSPECTED SIDS. PT ULTIMATELY DIED AT ER OF ANOTHER HOSP WHILE BEING TRANSPORTED. THE PT WAS VENTILATED WITH A BAG VALVE MAKE SYSTEM SINCE UNABLE TO INTUBATE. LATER, THE LIGHTING PROBLEM WAS REPRODUCABLE WITH THE SAME HANDLE AND BLADE BUT NOT WITH OTHER BLADES WHEN PLACED ON THE SAME HANDLE. THERE HAVE NOT BEEN PROBLEMS WITH THIS DISPOSABLE BLADE IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY SUPPORT PRODUCTS, INC. #0 MILLER DISPOSABLE LARYNGOSCOPE BLADE EQN SMITH INDUSTRIES MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY Death