BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP ENDOTRACHEAL TUBE HOLDER

    MDR report key: 276066 · Received April 29, 2000

    Report

    Report Number
    2020364-2000-00004
    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 STATED, IN THE PRESENCE OF THE REGISTERED NURSE, THAT A PT, (WEIGHT UNREPORTED), EXTUBATED. THE COMPLAINANT IS USING RSP ENDOTRACHEAL TUBE HOLDER, H4053, SIZE 3.5, WITH A PORTEX TUBE. THE PT WAS RE-INTUBATED 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. H4053 1466

    Patients

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