BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 17620 · Received September 27, 1994

    Report

    Report Number
    17620
    Event Type
    Death
    Date Received
    September 27, 1994
    Date of Event
    September 12, 1994
    Report Date
    September 27, 1994
    Manufacturer
    SHERIDAN CATHETER CORP.
    Product Code
    BTR
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    9/11/94 AT 10:50 PM - RESPIRATORY ARREST. PT HAD PROGRESSIVE VENTILATORY FAILURE. INTUBATED WITH #8-0 ET WITH 4 MAC. ET CUFF LEAKY. #8-0 ET REMOVED. REINTUBATED WITH #7-0 ET WITH #4 MAC. 9/12/94 AT 4:10 PM, PT TO OR FOR OPEN LUNG BIOPSY. ET CUFF LEAKY. ANESTHESIA ATTEMPTED TO CHANGE ET TUBE. UNSUCCESSFUL. STAT TRACH PERFORMED. PT ARRESTED. EXPIRED AT 4:10 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDOTRACHIAL TUBE BTR SHERIDAN CATHETER CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death