BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4102814 · Received September 19, 2014

    Report

    Report Number
    2031642-2014-01067
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR SERVICE WAS NOT REQUESTED. DEVICE IS PENDING REPAIR BY CUSTOMER.

    Description of Event or Problem · 1

    DURING TESTING THE CUSTOMER REPORTED AN EXHALATION AUTOZERO FAILURE OCCURENCE. THE PRODUCT SUPPORT ENGINEER ADVISED THE CUSTOMER REPLACE THE 3 STATION SOLENOID. THE CUSTOMER HAS ORDERED AND RECEIVED THE PART. NO REPAIR HAS BEEN PERFORMED TO DATE. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT, NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584392 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1