BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4821890 · Received June 5, 2015

    Report

    Report Number
    2031642-2015-01014
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    May 27, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REQUESTED AND THE CUSTOMER STATED THE PATIENT INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE MANUFACTURER¿S FIELD SERVICE ENGINEER EVALUATED THE UNIT WHILE ONSITE AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE CUSTOMER REPORTED THERE WAS PATIENT INVOLVEMENT WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365615 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1