BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6105406 · Received November 16, 2016

    Report

    Report Number
    2031642-2016-03091
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Report Date
    October 24, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REQUESTED AND WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SELECTING THE IPAP BUTTON ENABLES THE RATE SELECTION; DEVICE FAILS DIAGNOSTIC SCREEN TEST ON LEFT PERIPHERY. THE CUSTOMER REPORTED THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758105 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1