BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6423859 · Received March 22, 2017

    Report

    Report Number
    2031642-2017-01027
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Report Date
    February 24, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PATIENT INFORMATION WAS REQUESTED AND WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ROOT CAUSE FAILURE ANALYSIS STATES THAT THIS IS THE OLD STYLE NAV RING. NO FURTHER FI IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE FSE EVALUATED THE DEVICE WHILE ONSITE. THE FSE REPLACED THE FRONT BEZEL TO ADDRESS THE REPORTED PROBLEM. THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SETTING CHANGES CANNOT BE MADE VIA THE NAVIGATION RING OR TOUCH SCREEN. THE CUSTOMER REPORTED THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208069 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1