BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOLUME VENTILATOR

    MDR report key: 1222365 · Received November 5, 2008

    Report

    Report Number
    2183157-2008-00013
    Event Type
    Death
    Date Received
    November 5, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 8, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL DID NOT MAKE THE VENTILATOR AVAILABLE TO THE MFR'S INVESTIGATION FACILITY. THE HOSPITAL REQUESTED AN INITIAL MFR EVALUATION TAKE PLACE ON SITE AT THE HOSPITAL IN ANOTHER COUNTRY, COVIDIEN/NELLCOR PURITAN BENNETT COMPLIED AND DID EVALUATION OF ALARM FUNCTIONS IN 2008. ALL ALARMS FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT WHILE IN PATIENT USE, THE PATIENT CIRCUIT BECAME DISCONNECTED AND THE VENTILATOR VISUALLY ALARMED BUT FAILED TO AUDIBLY ALARM AT THE VENTILATOR AND AT THE NURSE CALL STATION. HOWEVER, IT WAS REPORTED THAT WHEN UNIT WAS CHECKED AFTER THE EVENT BY THE HOSPITAL BIOMEDICAL ENGINEER, THE NURSE CALL ALARM FUNCTIONED. IT WAS REPORTED THAT ALL AUDIBLE ALARMS FUNCTIONED ONE HOUR PRIOR TO THE PATIENT DISCONNECTION EVENT. IT WAS REPORTED ONE HOUR AFTER THE ALARMS WERE VERIFIED FUNCTIONAL PER RESPIRATORY THERAPIST ROUTINE CHECK, THE NURSE WENT INTO THE ROOM FOR A ROUTINE PATIENT CHECK. IT WAS REPORTED THAT THE NURSE FOUND THE PATIENT CIRCUIT DISCONNECTED AND THE PATIENT IN A CONDITION CONSISTENT WITH DEATH. IT WAS REPORTED THAT AN UNSUCCESSFUL RESUSCITATION ATTEMPT WAS MADE AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLUME VENTILATOR VENTILATOR CBK NELLCOR PURITAN BENNETT LP20

    Patients

    Seq Age Sex Outcome Treatment
    1 Death