BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWIVEL ELBOW

    MDR report key: 23693 · Received July 25, 1995

    Report

    Report Number
    MW1006564
    Event Type
    Death
    Date Received
    July 25, 1995
    Date of Event
    May 29, 1995
    Report Date
    July 21, 1995
    Manufacturer
    INTERSURGICAL, INC.
    Product Code
    BZA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS CONNECTED TO VENTILATOR. NURSE WENT IN TO CHECK ON PT. PT HAD EXPIRED. IT WAS NOTICED SWIVEL WAS DISCONNECTED FROM TRACHEOSTOMY TUBE. UNIT DID NOT ALARM. SWIVEL PIECE CONNECTS VENTILATOR HOSE TO TRACHEOSTOMY PIECE. RISK MANAGER STATED THEY HAVE NOTICED A TREND WITH SWIVEL PIECE. WHEN VENTILATOR IS IN MODE S INV, IT DOES NOT ALARM. WHEN VENTILATOR IS IN AC MODE, IT DOESN'T ALARM. THE PROBLEM LIES WITH THE DESIGN OF THE SWIVEL. IT SEEMS THAT BACK PRESSURE IS PRODUCED AND IT CAUSES THE PIECE TO DISCONNECT LEAVING VENTILATED PT WITHOUT AN OXYGEN SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIVEL ELBOW SWIVEL ELBOW BZA INTERSURGICAL, INC. MC4475 07693555

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death