BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 6598621 · Received May 30, 2017

    Report

    Report Number
    2031642-2017-01787
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Report Date
    May 16, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE MMI PCBA TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TOUCH SCREEN IS NOT WORKING. THE FIELD SERVICE ENGINEER (FSE) CLARIFIED THE TOUCH SCREEN DOES NOT RESPOND TO TOUCH AND CANNOT BE CALIBRATED. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379374 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1