BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6906649 · Received October 2, 2017

    Report

    Report Number
    6906649
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 10, 2017
    Report Date
    September 26, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    V60 BIPAP WAS IN USE ON THE PATIENT AND THE MACHINE STARTED ALARMING AND WENT INOPERATIVE AND STOPPED DELIVERING PRESSURES. RESPIRATORY THERAPISTS WERE AT BEDSIDE, MAKING PREPARATIONS TO INTUBATE THE PATIENT SO THE BIPAP WAS REMOVED IMMEDIATELY AND PATIENT WAS PLACED ON A 100% NON-REBREATHING MASK (NRB). PATIENTS SATS WERE AT 100% ON THE NRB. RESPIRATORY RATE WAS AT 18 AND HEAR RATE AT 74.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687835 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE CBK RESPIRONICS CALIFORNIA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR NO