BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1954346 · Received January 10, 2011

    Report

    Report Number
    2031642-2011-00004
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CHANGED EXHALATION FILTER. EXPIRATORY FILTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHEN THE VENTILATOR WAS POWERED ON, IT WOULD ALARM OCCLUSION SAFETY VALVE OPEN (SVO). THE VENTILATOR WAS NOT IN USE ON A PATIENT, THEREFORE, THERE WAS NO PATIENT HARM OR INVOLVEMENT. THE MANUFACTURER'S SERVICE TECHNICIAN RECOMMENDED THE CUSTOMER REPLACE THE EXHALATION FILTER. THE CUSTOMER REPLACED THE EXHALATION FILTER AND THE VENTILATOR POWERED UP WITH NO FURTHER SVO ALARMING, INDICATING A LIKELY OCCLUSION OF THE EXHALATION FILTER. WHEN AN OCCLUSION IS DETECTED DURING NORMAL VENTILATION, THE VENTILATOR WILL OPEN THE SAFETY VALVE WHICH ALLOWS THE PATIENT TO BREATH THROUGH THE SYSTEM. WHEN THE SAFETY VALVE IS OPEN, IT IS ACCOMPANIED BY AN ALARM AND A MESSAGE IN THE DISPLAY. WHEN THE FILTER IN USE ON THIS VENTILATOR BECAME OCCLUDED, IT ALERTED THE USER WITH AN OCCLUSION-SVO ALARM/MESSAGE. THIS IS BEING REPORTED AS MDR DUE TO USER ERROR IN MAINTENANCE CONTRIBUTING TO THE EVENT, WHICH WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. FILTER REPLACEMENT MUST BE PERFORMED PER MANUFACTURER RECOMMENDATIONS AND SPECIFIED INTERVALS. THERE WAS NO MALFUNCTION OF THE DEVICE OR THE SAFETY VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1