BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1901736 · Received November 17, 2010

    Report

    Report Number
    2031642-2010-00298
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR DOES NOT RETURN PARTS DUE TO CUSTOM COSTS. PRINTED CIRCUIT BOARD (PCB), FLOW SENSOR. NO PARTS RETURNED DUE TO CUSTOM COSTS.

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PATIENT DUE TO A FLOW SENSOR FAILURE. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. THE DISTRIBUTOR WILL REPLACE THE EXHALATION FLOW SENSOR AND MAIN, SENSOR, ANALOG AND CPU PCBS BOARD TO ADDRESS THE REPORTED EVENT.

    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