BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6518418 · Received April 25, 2017

    Report

    Report Number
    2031642-2017-01446
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Report Date
    March 30, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER INVESTIGATION, A VISUAL INSPECTION OF THE UI FRONT (B)(6) ASSEMBLY REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. DURING TESTING, THE NAV-RING WAS ERRATIC WHILE CHANGING PARAMETERS AND SETTINGS. AN INTERIOR VISUAL INSPECTION OF THE NAV-RING REVEALED SIGNS OF CONTAMINATION FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV-RING) MATRIX. THE DETERMINATION COULD BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS NOT BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM. CONTAMINATION BUILDUPS WERE FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV-RING) MATRIX THAT CAUSES THE NAV-RING NOT FUNCTIONING CORRECTLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SCREEN IS FLICKERING; CANNOT READ VALUES. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT; THE DEVICE WAS PREPARED FOR THE PATIENT BUT WAS NOT USED ON THE PATIENT; THE ISSUE WAS RECOGNIZED IN PROCESS OF SETTING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301155 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR