BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL/PEDIATRIC ENDOTRACHEAL TUBE HOLDER

    MDR report key: 364679 · Received December 5, 2001

    Report

    Report Number
    2020364-2001-00006
    Event Type
    Malfunction
    Date Received
    December 5, 2001
    Date of Event
    November 1, 2001
    Report Date
    November 7, 2001
    Manufacturer
    RESPIRATORY SUPPORT PRODUCTS, INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY ALLEGES TWO EVENTS WHERE THE HOLDER SECURING THE ENDOTRACHEAL TUBE TO THE PT WAS DISCONNECTING FROM ITS ADHESIVE BASE. THERE HAS NOT BEEN ANY PT COMPROMISE DUE TO THESE ALLEGED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54819 NEONATAL/PEDIATRIC ENDOTRACHEAL TUBE HOLDER HOLDER, ENDOTRACHEAL TUBE CBH RESPIRATORY SUPPORT PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO RSP ENDOTRACHEAL TUBE