BEUDAMED
    FDA Adverse Event Death Summary report: N

    V200 VENTILATOR

    MDR report key: 1668218 · Received April 27, 2010

    Report

    Report Number
    2031642-2010-00073
    Event Type
    Death
    Date Received
    April 27, 2010
    Date of Event
    March 29, 2010
    Report Date
    March 30, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS IN PROGRESS.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS REPORTED BY THE CUSTOMER AND VIEWED PER VIDEOTAPE PROVIDED BY THE MATERIALS MANAGER: ON (B) (6) 2010, THE FEMALE PATIENT WAS IN THE ICU AND MOVED TO THE (B) (6) FACILITY WHICH IS LOCATED IN THE HOSPITAL, AND WAS BEING SET UP ON THE VENTILATOR. THE PATIENT WAS REPORTED TO BE VENTILATOR DEPENDENT, VERY ILL AND LISTED AS DNR. THE VENTILATOR RESTARTED AND ALARMED DURING SET UP. THE RESPIRATORY THERAPIST (RT) WAITED THROUGH THE COUNTDOWN AND PROCEEDED TO PUT THE PATIENT ON THE VENTILATOR AFTER THE RESTART COMPLETED. THEN EVERYONE LEFT THE ROOM. THE VENTILATOR RESTART AND ALARM WAS VISIBLE ON THE VIDEO. APPROX. 48 MINUTES LATER, THE VENTILATOR RESTARTED AGAIN WHICH WAS VISIBLE VIA A COUNTDOWN ON THE MONITOR SCREEN. APPROX. 4 MINUTES LATER, THE SCREEN WENT BLANK AND ANOTHER RESTART OCCURRED. THERE APPEARED TO BE NO IMMEDIATE RESPONSE FROM STAFF AT THE OCCURRENCE OF THE VENTILATOR RESTART; HOWEVER IT WAS ALSO REPORTED THAT SOMEONE WAS WALKING BY AND HEARD THE VENTILATOR BACKUP ALARM SOUNDING. STAFF CAME INTO THE ROOM, AND THE PATIENT CODED AT 4:56 PM. THE PATIENT WAS RESUSCITATED BUT LATER EXPIRED. IT WAS NOT EXPLAINED IF THE PATIENT EXPIRED DUE TO NATURAL CAUSES. THERE WAS REMOTE MONITORING IN PLACE, INCLUDING THE VENTILATOR REMOTE ALARM VIA A CABLE CONNECTED TO THE WALL. THE UNIT WAS HARD WIRED TO A NURSE¿S STATION. THE REMOTE ALARM SYSTEM IS SETUP TO LIGHT A VISUAL INDICATOR AND MAKE SOMEONE RESET IT. THE CUSTOMER REPORTED THE UNIT ALARMED BUT DID NOT KNOW IF THE NURSE STATION ALARM ANNUNCIATED. THE RT WORKS FOR THE HOSPITAL THAT THE (B) (6) HOSPITAL IS LOCATED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death