BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2232030 · Received September 1, 2011

    Report

    Report Number
    2031642-2011-00311
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    June 4, 2011
    Report Date
    August 18, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    WHILE SERVICING THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE VENTILATOR LOG HISTORY INDICATED THERE HAD BEEN A PAST OCCURRENCE OF A GAS SUPPLIES LOST: SAFETY VALVE OPEN ALARM. THERE WAS NO SUCH EVENT REPORTED BY THE CUSTOMER, AND THERE WAS NO REPORTED PATIENT HARM OR INVOLVEMENT. LOSS OF BOTH GAS SUPPLIES WILL AFFECT THE FUNCTION OF THE VENTILATOR. IF THE VENTILATOR IS OPERATING IN NORMAL VENTILATION MODE AND NO AIR FLOW IS DETECTED, AND THE VENTILATOR CANNOT SWITCH TO AN OXYGEN SOURCE AS IT'S NOT DETECTED BY THE OXYGEN PRESSURE SWITCH OR IS DISCONNECTED, THE VENTILATOR WILL ALARM AND THE SAFETY VALVE WILL OPEN. THE SERVICE TECHNICIAN COULD NOT DUPLICATE A LOSS OF BOTH GAS SUPPLIES. EXTENDED SELF TESTING AND FINAL APPLICABLE TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    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