BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4233395 · Received November 6, 2014

    Report

    Report Number
    2031642-2014-01382
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 9, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 IN USE, BUT THERE WAS NO PATIENT HARM REPORTED. 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. THE BIOMEDICAL TECHNICIAN CLEANED THE FILTER AND THE ISSUE WAS CORRECTED. THE UNIT PASSED ALL APPLICABLE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713957 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1