BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3854406 · Received June 6, 2014

    Report

    Report Number
    2031642-2014-00453
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 4, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED DUE TO A 35VOLT FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. A 35 VOLT FAILURE OCCURRENCE MAY RESULT IN A SHUT DOWN OF THE DEVICE WITH ALARM DURING NORMAL VENTILATION OPERATION. THE MANUFACTURERS SERVICE PROVIDER REPLACED THE POWER MANAGEMENT PCB BOARD TO ADDRESS THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332031 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1