BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2223674 · Received August 25, 2011

    Report

    Report Number
    2031642-2011-00279
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 4, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    KINKED TUBING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PATIENT DUE TO AN INHALATION AUTOZERO FAILURE. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. REVIEW OF THE VENTILATOR DIAGNOSTIC LOG HISTORY CONFIRMED A VENT INOP OCCURRENCE DUE TO AN INHALATION AUTOZERO FAILURE. UPON EVALUATION OF THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE VENTILATOR FAILED EXTENDED SELF TESTING (EST) WITH THE VENTILATOR CLOSED. THE SERVICE TECHNICIAN REPORTED THE VENTILATOR PASSED EST WHEN THE UPPER AND LOWER VENTILATOR ENCLOSURES WERE SEPARATED, CONCLUDING THAT A PRESSURE TUBE WAS KINKED WHEN THE ENCLOSURES WERE ASSEMBLED TOGETHER DURING USE. THE SERVICE TECHNICIAN HAD RECENTLY COMPLETED SERVICE ON THE VENTILATOR. THE SERVICE TECHNICIAN REROUTED THE PRESSURE TUBE TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED PER OPERATING SPECIFICATIONS. THIS ISSUE WAS INDUCED DURING PREVIOUS SERVICE BY THE MANUFACTURER'S SERVICE TECHNICIAN.

    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