BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 6960481 · Received October 18, 2017

    Report

    Report Number
    2031642-2017-03366
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Report Date
    September 29, 2017
    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

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

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER CONFIRMED THE REPORTED PROBLEM AND REPLACED THE MMI PCB TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TOUCHSCREEN UNRESPONSIVE. THE INABILITY TO MAKE CHANGES TO THE PATIENT SETTINGS MAY BE DETRIMENTAL TO THE PATIENT. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739961 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1