BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4233374 · Received November 6, 2014

    Report

    Report Number
    2031642-2014-01378
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 29, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    UPON SETUP OF THE VENTILATOR AFTER CONVERSION SERVICE, THE CUSTOMER REPORTED THE UNIT WOULD NOT TRANSITION FROM AC POWER TO BATTERY POWER. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. THE FSE REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. THE FSE REPORTED INSPECTION OF THE POWER SUPPLY REMOVED FROM THE UNIT OBSERVED THE MOUNTING SCREWS ON THE FAN SHROUD WERE INVERTED AS MOUNTED FROM THE INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713394 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1