BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2842090 · Received November 21, 2012

    Report

    Report Number
    2031642-2012-00514
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    November 14, 2012
    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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING DUE TO A AN OCCLUSION. THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPORTED THE BLOWER WAS FAILING. AN OCCLUSION DURING USE IN NORMAL VENTILATION MODE OPERATION MAY RESULT IN NO FLOW / VENTILATION DURING A BREATH CYCLE. THE SERVICE TECHNICIAN WILL REPLACE THE BLOWER TO ADDRESS THE REPORTED PROBLEM.

    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