BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3202756 · Received July 2, 2013

    Report

    Report Number
    2031642-2013-00316
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 17, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED WHILE THE DEVICE WAS IN OPERATION, IT WAS TURNED OFF DUE TO AN ODOR OF OVERHEATING. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. THE MANUFACTURERS SERVICE TECHNICIAN REPORTED THE POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPORTED A VOLTAGE SUPPLY FAULT HAD ALSO OCCURRED AND THE MOTOR CONTROLLER PCB BOARD WAS REPLACED TO ADDRESS THE REPORTED PROBLEM. APPLICABLE TESTING WAS PERFORMED, INCLUDING ALARMS, AND TESTS PASSED WITH NO FAULTS CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WOULD NOT PROCEED THROUGH POWER ON SELF TEST AFTER POWERED ON, AND VISUAL LED ALARMS WERE PRESENT. REVIEW OF THE DEVICE DIAGNOSTIC LOG HISTORY NOTED A SHUT DOWN OF THE UNIT AND FAILURE TO SUCCESSFULLY RESTART INTO NORMAL VENTILATION MODE DUE TO A POWER ON SELF TEST FAILURE. DEVICE EVALUATION IS CURRENTLY IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300998 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1