BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM PSV

    MDR report key: 241362 · Received September 17, 1999

    Report

    Report Number
    241362
    Event Type
    Death
    Date Received
    September 17, 1999
    Date of Event
    August 15, 1999
    Report Date
    September 16, 1999
    Manufacturer
    RESPIRONICS
    Product Code
    MNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED ON 8/10/99 FOR INITIATION OF PHYSICAL REHABILITATION FOLLOWING MOTOR VEHICLE ACCIDENT ON 6/19/99. PT WAS TRANSFERRED HERE FROM TRAUMA CENTER FOLLOWING APPROX 2 MONTHS OF HOSPITALIZATION. PT IS AWAKE, ALERT, FOLLOWS COMMANDS, AND RESPONDS BY WRITING APPROPRIATE ANSWERS. PT ABLE TO USE CALL LIGHT. PT FOUND CYANOTIC, PULSELESS, APNEIC, AND UNRESPONSIVE WITH BIPAP DISCONNECTED FROM PT TRACHEOTOMY. BIPAP FOUND LYING IN BED NEXT TO PT AND NOT ALARMING. CODE BLUE INSTITUTED, PT PLACED ON VENTILATOR AND TRANSPORTED TO ICCU. PT REMOVED FROM VENTILATOR SUPPORT ON 9/9/99 AND EXPIRED. HUMAN ERROR MAY HAVE BEEN INVOLVED WITH APPLICATION OF CORRUGATED TUBING, WHICH IS CONTRAINDICATED WITH THE HEATING UNIT AND HUMIDIFIER ON THIS EQUIPMENT. THE APPEARANCE OF THE TUBING ALMOST IDENTICAL FOR INNER LUMEN, THEREFORE UNABLE TO DETERMINE IF INTERIOR LUMEN IS SMOOTH OR CORRUGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM PSV VENTILATOR/BIPAP MNS RESPIRONICS 7700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death| S HUDSON (RCI) HUMIDIFIER MODEL#CONCHA THERM.