BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2071114 · Received April 27, 2011

    Report

    Report Number
    2031642-2011-00116
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING DURING USE ON A PATIENT DUE TO A PATIENT CIRCUIT OCCLUSION. THE CUSTOMER REPORTED THAT WATER HAD GOTTEN INTO THE UNIT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM OR INVOLVEMENT. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE REPORTED COMPLAINT. THE SERVICE TECHNICIAN REPORTED DURING TESTING THERE WAS NO BLOWER VOLTAGE, WHICH COULD RESULT IN NO VENTILATION DURING OPERATION. THE SERVICE TECHNICIAN REPLACED THE MOTOR CONTROLLER BOARD TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED AND 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