BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 6025759 · Received October 13, 2016

    Report

    Report Number
    2031642-2016-02684
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Report Date
    September 26, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REQUESTED AND WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DISPLAY IS BLACK AND WHITE. THE FIELD SERVICE ENGINEER (FSE) REPORTED THE VENTILATOR DID NOT CONTINUE TO PROVIDE VENTILATION TO THE PATIENT. THE CUSTOMER REPORTED THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677364 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1