BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 5513366 · Received March 21, 2016

    Report

    Report Number
    2031642-2016-00710
    Event Type
    Malfunction
    Date Received
    March 21, 2016
    Report Date
    February 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REQUESTED AND WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MMI PCBA AND TOUCHFRAME ASSEMBLY TO ADDRESS THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TOUCH SCREEN DOES NOT RESPOND TO TOUCH. THE CUSTOMER REPORTED PATIENT INVOLVEMENT WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171325 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1