BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4182460 · Received October 17, 2014

    Report

    Report Number
    2031642-2014-01246
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 24, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING AND WOULD NOT POWER UP AND THE AC MAINS AND BATTERY CHARGING LEDS WERE FLASHING. THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. AS THE DEVICE IS OUT OF WARRANTY THE HOSPITAL BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT ENGINEER (PSE) FOR ASSISTANCE. PSE ADVISED THE BIOMEDICAL ENGINEER EVALUATE AND/OR REPLACE THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. NO FOLLOW-UP INFORMATION HAS BEEN PROVIDED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660803 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1