BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP ENDOTRACHEAL TUBE HOLDERS, ADULT

    MDR report key: 39987 · Received September 5, 1996

    Report

    Report Number
    2020364-1996-00003
    Event Type
    Other
    Date Received
    September 5, 1996
    Date of Event
    August 2, 1996
    Report Date
    September 5, 1996
    Manufacturer
    SIMS/RESPIRATORY SUPPORT PRODUCTS, INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TUBE HOLDER WAS IN USE 3 DAYS WHEN THE TUBE HOLDER SEPARATED FROM THE FOAM. THE PT EXTUBATED. PT DATA IS NOT AVAILABLE. THE INACTIVE PT, RECOVERING FROM CARDIO-THORACIC SURGERY, HAD AVERAGE ORAL SECRETIONS. THE PT WAS SEDATED. THE ENDOTRACHEAL TUBE HOLDER WAS CLEANED WITH A WIPE USING A CLOTH AND WARM WATER WITH A BABY BATH MIXTURE. THE PT WAS SUCCESSFULLY RE-INTUBATED. THE ENDOTRACHEAL TUBE HOLDER WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP ENDOTRACHEAL TUBE HOLDERS, ADULT ENDOTRACEHAL TUBE HOLDERS, ADULT CBH SIMS/RESPIRATORY SUPPORT PRODUCTS, INC. K2000 175

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other