BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4133661 · Received October 1, 2014

    Report

    Report Number
    2031642-2014-01130
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUT OF WARRANTY REPAIR. NO REQUEST FOR MANUFACTURER SERVICE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT HE WAS PERFORMING A PREVENTIVE MAINTENANCE ON THE VENT AND THE UNIT STOP WORKING AND WOULD NOT POWER ON. THE BIOMEDICAL ENGINEER SAID THAT HE INSTALLED ANOTHER POWER MANAGEMENT BOARD AND HE SMELL AN OVERHEATING ODOR AND THE UNIT STILL WOULD NOT POWER UP. THE VENTILATOR WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE PRODUCT SUPPORT ADVISED HIM TO REPLACED THE PM BOARD, MOTOR CONTROLLER BOARD AND CPU BOARD AT THE SAME TIME. THE BIOMEDICAL ENGINEER STATED THAT AFTER REPLACING THE RECOMMENDED BOARDS THE UNIT POWERED UP. THE BIOMEDICAL ENGINEER TESTED THE UNIT AND PASSED ALL TESTING AND PREVENTIVE MAINTENANCE. THE UNIT IS NOW BACK IN SERVICE. POWER FAILURE DUE TO LOSS OF AC POWER MAY RESULT IN SHUTDOWN OF DEVICE DURING NORMAL VENTILATION OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611507 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1