BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3951478 · Received July 22, 2014

    Report

    Report Number
    2031642-2014-00714
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 30, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED DUE TO AN OXYGEN DEVICE FAILED OCCURRENCE. UPON AN OXYGEN DEVICE FAILED OCCURRENCE, THE VENTILATOR CONTINUES TO PROVIDE VENTILATORY SUPPORT TO THE PATIENT USING AN AIR GAS SOURCE. LOSS OF THE OXYGEN SOURCE CAN BE DETRIMENTAL TO A PATIENT IF THIS TYPE OF EVENT OCCURS DURING NORMAL VENTILATION MODE USE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE REPORTED WHEN O2 WAS SET TO 80% ON THE DEVICE, THE VENTILATOR WOULD ALARM AND THE TEST CERTIFIER DISPLAYED 21%. THE FSE REPLACED THE CPU PCB BOARD TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428783 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1