BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4141079 · Received October 3, 2014

    Report

    Report Number
    2031642-2014-01141
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 8, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WAS ALARMING DUE TO A BLOWER TEMPERATURE HIGH OCCURRENCE. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. A PROLONGED BLOWER TEMPERATURE HIGH OCCURRENCE MAY RESULT IN A VENT INOP DURING NORMAL VENTILATION OPERATION. VENT INOP IS A HIGH PRIORITY CONDITION THAT PRECLUDES SAFE OPERATION OF THE VENTILATOR. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURER'S PRODUCT SUPPORT (PSE) FOR ASSISTANCE, AND REPORTED THE UNIT HAD RECENTLY RECEIVED SERVICE BEFORE THE REPORTED PROBLEM OCCURRED. PSE ADVISED THE BIOMEDICAL ENGINEER CHECK THE FANS AND AIRFLOW. THE BIOMEDICAL ENGINEER REPORTED THE FAN WAS INSTALLED INCORRECTLY WHICH RESULTED IN THE REPORTED PROBLEM. THE BIOMEDICAL ENGINEER REPORTED THE FAN WAS PROPERLY INSTALLED AND THE REPORTED PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619332 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1