BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5883709 · Received August 17, 2016

    Report

    Report Number
    2031642-2016-02058
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Report Date
    July 29, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED ISSUE OF VALUE AUTOMATICALLY CHANGED ON SETTING CHANGE SCREEN ON THE V60 UNIT. THE ISSUE WAS CAUSED BY NAVIGATION RING MALFUNCTION. THE NAV RING WILL BE REPLACED WHEN PARTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE SERVICE TECHNICIAN REPLACED THE FRONT BEZEL TO CORRECT THE REPORTED PROBLEM. UNIT WAS CHECKED OVERALL, CLEANED, RUN IN TESTS AND FUNCTIONALLY TESTED. UNIT WAS RETURNED TO THE CUSTOMER FOR PATIENT USE.

    Additional Manufacturer Narrative · 1

    THE FRONT BEZEL WAS RECEIVED AT THE V60 VENT MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY EVIDENCE OF DAMAGE OR CONTAMINATION. THE ROTARY ADJUSTMENT ASSEMBLY / NAV RING OVERLAY HAD NO NOTCH. THE FRONT BEZEL ASSEMBLY WAS INSTALLED IN A TEST VENTILATOR TO VERIFY AND TEST THE FUNCTIONALITY OF THE ROTARY ADJUSTMENT ASSEMBLY. THE NAV RING WAS NONRESPONSIVE WHILE CHANGING PARAMETERS AND SETTINGS. THE ROTARY ADJUSTMENT ASSEMBLY (NAV RING) WAS REMOVED FROM THE FRONT BEZEL ASSEMBLY TO PERFORM AN INTERNAL VISUAL INSPECTION. VISUAL INSPECTION IDENTIFIED SIGNS OF CONTAMINATION ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV RING) MATRIX. CONTAMINATION BUILDUPS WERE FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV RING) MATRIX WHICH CAUSED THE NAV RING NOT TO FUNCTION.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VALUE AUTOMATICALLY CHANGED ON SETTING CHANGE SCREEN ON THE V60 UNIT, EVEN THOUGH A USER WAS NOT CHANGING IT. NAV RING DID NOT FUNCTION EITHER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535207 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1