BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1241588 · Received November 25, 2008

    Report

    Report Number
    2031642-2008-00233
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VENTILATOR RETURNED TO FACTORY FOR EVALUATION AND ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR RESTARTED WHILE IN USE ON A PATIENT WHEN THE HOSPITAL RESPIRATORY THERAPIST POWERED ON A CARDIOPULMONARY MANAGEMENT SYSTEM UNIT THAT WAS ATTACHED TO THE VENTILATOR. THE CUSTOMER REPORTED THE VENTILATOR DID ALARM AND THERE WAS NO PATIENT HARM. THE MANUFACTURER'S FIELD SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN REPORTED FINDING THE CARDIOPULMONARY MANAGEMENT SYSTEM UNIT WAS NOT SET TO INTERFACE WITH THE VENTILATOR. THE FIELD SERVICE TECHNICIAN CHANGED THE SETTINGS ON THE CARDIOPULMONARY MANAGEMENT SYSTEM UNIT TO INTERFACE WITH THE VENTILATOR, AND UPON ACTIVATING THE CHANGES, THE VENTILATOR RESTARTED.

    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