BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3983596 · Received August 6, 2014

    Report

    Report Number
    2031642-2014-00791
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 8, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR ALARMED AND TURNED OFF WHEN THE PATIENT CIRCUIT WAS DISCONNECTED. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS SERVICE ENGINEER REPLACED THE POWER MANAGEMENT PCB BOARD TO ADDRESS THE REPORTED PROBLEM. FINAL APPLICABLE TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460819 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1