BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANCHOR FAST

    MDR report key: 1957988 · Received January 3, 2011

    Report

    Report Number
    1957988
    Event Type
    Death
    Date Received
    January 3, 2011
    Date of Event
    October 19, 2010
    Report Date
    December 21, 2010
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING TURNED TO CHANGE LINENS WHEN THE ETT ENDOTRACHEAL TUBE MIGRATED 3 CM (FROM 20CM-17CM AT THE LIP). PHYSICIAN NOTIFIED AND RT RESPIRATORY THERAPIST ASSESSED BREATH SOUNDS. DURING ASSESSMENT, PATIENT WENT INTO ASYSTOLE AND CODE WAS CALLED. PATIENT WAS MADE DNR DO NOT RESUSCITATE PRIOR TO REINTUBATION.======================HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE FAILED TO SECURE ETT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER CBH HOLLISTER INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| R