BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5969514 · Received September 22, 2016

    Report

    Report Number
    2031642-2016-02424
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Report Date
    August 30, 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

    THE MANUFACTURER'S SERVICE TECHNICIAN CHECKED THE UNIT BUT THE REPORTED ISSUE OF SET VALUES ON THE V60 VENT SCREEN CHANGED, EVEN IF THE USER WAS NOT OPERATING THE UNIT, WAS NOT DUPLICATED. HOWEVER, IT WAS IDENTIFIED THAT THE NAV RING DID NOT OPERATE. THE FRONT BEZEL WAS REPLACED DUE TO NAV RING NOT OPERATING.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED NAV RING DID NOT OPERATE PROPERLY, CAUSING THE REPORTED ISSUE. RESOLUTION AND DISPOSITION: THE NAVIGATION RING WILL BE REPLACED WHEN THE PART ARRIVES TO THE SERVICE CENTER.

    Additional Manufacturer Narrative · 1

    USER INTERFACE FRONT BEZEL ASSEMBLY WAS RECEIVED AT THE V60 VENT MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION OF THE UI FRONT BEZEL ASSEMBLY REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. THE ROTARY ADJUSTMENT ASSEMBLY / NAV RING OVERLAY HAD NO NOTCH. THE UI FRONT BEZEL ASSEMBLY WAS INSTALLED INTO A TEST VENTILATOR TO VERIFY AND TEST THE FUNCTIONALITY OF THE ROTARY ADJUSTMENT ASSEMBLY. CHANGING THE PARAMETERS AND SETTINGS WAS PERFORMED TO VERIFY THE NAV RING FUNCTIONALITY. THE NAV RING WAS ERRATIC WHILE CHANGING PARAMETERS & SETTINGS. THE ROTARY ADJUSTMENT ASSEMBLY (NAV RING) WAS REMOVED FROM THE FI UI FRONT BEZEL ASSEMBLY TO PERFORM AN INTERNAL VISUAL INSPECTION. THERE WERE SIGNS OF CONTAMINATION FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV RING) MATRIX. THE ROOT CAUSE FOR THE CUSTOMER'S REPORT OF NAV RING IS OPERATING BY ITSELF WAS CONTAMINATION BUILDUPS FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV RING) MATRIX, CAUSING THE NAV RING NOT FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT AFTER THE USER SET THE VALUES ON THE V60 VENT SCREEN, THE FIGURES CHANGED, EVEN IF THE USER WAS NOT OPERATING THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622443 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1