BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3933162 · Received July 14, 2014

    Report

    Report Number
    2031642-2014-00674
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 17, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURER'S SERVICE. CUSTOMER REPAIR .

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING AND THE TIDAL VOLUME READING WAS LOW. THE CUSTOMER REPORTED THE UNIT WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT (PSE) FOR ASSISTANCE. THE BIOMEDICAL ENGINEER REPORTED THE VENTILATOR FLOW RATES ARE ADEQUATE AND ADJUSTABLE. PSE RECOMMENDED AIR DELIVERY AND PRESSURE TESTS BE PERFORMED. THE CUSTOMER WAS CONTACTED FOR FOLLOWUP INFORMATION; AWAITING RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409672 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1