BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2123697 · Received June 14, 2011

    Report

    Report Number
    2031642-2011-00187
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL MANUFACTURER'S REPRESENTATIVE REPORTED THAT DURING TRAINING DEMONSTRATION WITH THE DEVICE, THE VENTILATOR FAILED DUE TO A PRESSURE SENSOR FAILURE OCCURRENCE. THE DEVICE WAS NOT IN USE ON A PATIENT; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURER'S SERVICE TECHNICIAN REPLACED THE CPU PCB BOARD TO ADDRESS THE FINDINGS. REVIEW OF THE DEVICE DIAGNOSTIC LOG HISTORY NOTED A SHUT DOWN OF THE UNIT AND FAILURE TO SUCCESSFULLY RESTART INTO VENTILATION. UPON LOSS OF POWER, A POWER FAIL ALARM WILL ACTIVATE AND ALTERNATIVE VENTILATION SHOULD BE PROVIDED. THE CPU PCB BOARD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND A COMPONENT FAILURE WAS IDENTIFIED.

    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