BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 279740 · Received May 25, 2000

    Report

    Report Number
    MW1019009
    Event Type
    Injury
    Date Received
    May 25, 2000
    Date of Event
    March 23, 2000
    Report Date
    May 12, 2000
    Manufacturer
    SALTER LABORATORIES
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OVER THE YEARS, SEVERAL DEVICES HAVE BEEN MODIFIED IN ORDER TO PROMOTE PT SAFETY, ESPECIALLY WITH ANESTHESIA EQUIPMENT. ONE TYPE OF MODIFICATION HAS BEEN THE CHANGE OF CONNECTIONS SO LINES CANNOT BE INTERCHANGED WHICH COULD CAUSE HARM. HOSP WOULD LIKE TO BRING TO FDA'S ATTENTION THAT THE SMALL VOLUME NEBULIZER AND ENDOTRACHEAL TUBE DISCUSSED IN THIS REPORT DIRECTLY CONNECT WITH EACH OTHER, ALLOWING NO PT EXHALATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALTER LABS SMALL VOLUME NEBULIZER CAF SALTER LABORATORIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R