BEUDAMED
    FDA Adverse Event Death Summary report: N

    DOUBLE SWIVEL ELBOW T90

    MDR report key: 183358 · Received August 19, 1998

    Report

    Report Number
    183358
    Event Type
    Death
    Date Received
    August 19, 1998
    Date of Event
    July 14, 1998
    Report Date
    July 15, 1998
    Manufacturer
    INTERSURGICAL INC.
    Product Code
    BZO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR HOSE SWIVEL ELBOW BECAME DETACHED FROM TRACHOSTOMY TUBE, PT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE SWIVEL ELBOW T90 VENTILATOR CONNECTION SWIVEL BZO INTERSURGICAL INC. 1994-3-A 822172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death| O UNFENESTRATED, MFR: SIMS/PORTEX KEENE, NH| REF # 502090, LOT # 804787| D.I.C. TRACHOSTOMY TUBE, I.D. 9MM, UNCUFFED,