BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP ENDOTRACHEAL TUBE HOLDER

    MDR report key: 276069 · Received April 29, 2000

    Report

    Report Number
    2020364-2000-00003
    Event Type
    Other
    Date Received
    April 29, 2000
    Date of Event
    March 24, 2000
    Report Date
    April 26, 2000
    Manufacturer
    SIMS/RESPIRATORY SUPPORT PRDTS
    Product Code
    CBH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Description of Event or Problem · 1

    THE NURSE TECHNICIAN REPORTED, IN THE PRESENCE OF THE REGISTERED NURSE, THAT A PT, (WEIGHT UNREPORTED), EXTUBATED. THE COMPLAINT IS USING RSP ENDOTRACHEAL TUBE HOLDER, H4052, SIZE 3.0, WITH A PORTEX TUBE. THE TUBE SLID IN THE DOCTOR'S HAND WHEN THE TUBE WAS BEING REPOSITIONED. SLIDING OF THE TUBE MAY HAVE BEEN THE CASE OF A PULMONARY HEMORRHAGE. THE PT WAS TRANSFUSED AND VENT SETTINGS WERE INCREASED. THE INFANT WAS REINTUBATED WITHOUT INCIDENT. THE PRODUCT WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP ENDOTRACHEAL TUBE HOLDER ENDOTRACHEAL TUBE HOLDER CBH SIMS/RESPIRATORY SUPPORT PRDTS H4052 1517

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DAY Other NOT APPLICABLE.