BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2071147 · Received April 27, 2011

    Report

    Report Number
    2031642-2011-00127
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ONSITE TO PERFORM PREVENTIVE MAINTENANCE ON THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE DEVICE WAS RESTARTING AND DISPLAYING AN INHALATION AUTOZERO TEST FAILURE DURING POWER ON SELF TEST. THE CUSTOMER DID NOT REPORT THE OCCURRENCE DURING ANY PREVIOUS USAGE. THERE WAS NO PATIENT HARM REPORTED. AN AUTOZEROING FAILURE MAY AFFECT THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT, THEREFORE THIS EVENT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF AN AUTOZEROING FAILURE WERE TO RECUR WHILE IN USE ON A PATIENT. THE SERVICE TECHNICIAN REPLACED THE SENSOR PCB BOARD TO CORRECT THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND THE VENTILATOR PASSED PER 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