BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4082402 · Received September 11, 2014

    Report

    Report Number
    2031642-2014-01021
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Report Date
    August 19, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN NORMAL VENTILATION DUE TO AN EXHALATION MOTOR ERROR. THE DEVICE WAS IN USE ON A PATIENT , THE CUSTOMER REPORTED NO PATIENT HARM. VENT INOP, WHEN IN USE IN NORMAL VENTILATION MODE OPERATION, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. THE CUSTOMERS BIOMED REPORTED THE EXHALATION VALVE WAS REPLACED AND THE UNIT HAS BEEN RETURNED TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561849 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1