BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR FAST

    MDR report key: 2030012 · Received March 15, 2011

    Report

    Report Number
    2030012
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    January 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PRIOR TO EVENT, PATIENT WAS LOG ROLLED, REPOSITIONED, AND RESTRAINED. PATIENT REMAINED SEDATED AND COMFORTABLE. AT 0235, THE VENTILATOR ALARMED AND RN ENTERED ROOM AND FOUND THE PATIENT TO BE EXTUBATED, BUT WITH ARMS REMAINING AT SIDES, THOUGH THEY WERE STILL RESTRAINED. PATIENT BAGGED WITH 100% O2 OXYGEN AND PLACED ON AFM AIR FLOW METER OF 100%. PT TOLERATED IT WELL. MD WAS AT BEDSIDE. AT THE BEGINNING OF THE SHIFT, AS STATED IN REPORT, ETT HOLDER HAD BEEN CHANGED AND TUBE WAS PLACED TO THE RIGHT SIDE. WHEN RN ENTERED ROOM AT 1930, THE STRAP THAT GOES AROUND THE ETT HAD COME OFF AND TUBE SHIFTED TO OTHER SIDE OF THE MOUTH. ETT WAS REATTACHED TO HOLDER AND WAS SECURED TIGHTLY. ETT HOLDER REMAINED SECURE THROUGHOUT THE NIGHT. DUE TO THE PATIENT BEING DIAPHORETIC, DUODERM CHEEK PADS WERE NOTED TO BE SLIGHTLY LOOSE AND DEVICE HAD TO BE RESECURED.

    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 39 YR OTHER