BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2192269 · Received August 4, 2011

    Report

    Report Number
    2031642-2011-00242
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 12, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WAS ALARMING DURING USE DUE TO A HIGH BLOWER TEMPERATURE. A HIGH BLOWER TEMPERATURE OCCURRENCE WILL RESULT IN A VENT INOP CONDITION. 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 CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE BLOWER TO ADDRESS THE REPORTED PROBLEM. FINAL APPLICABLE TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1