BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5211958 · Received November 9, 2015

    Report

    Report Number
    2031642-2015-02320
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Report Date
    October 13, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REQUESTED AND THE CUSTOMER STATED IT IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY BECAME BLANK, AND THE DEVICE ALARMED WITH A VENT INOP OCCURRENCE DUE TO A MACHINE AND PROXIMAL PRESSURE SENSOR FAILURE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742787 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1