BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4100282 · Received September 18, 2014

    Report

    Report Number
    2031642-2014-01064
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    July 9, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WAS ALARMING DUE TO A HIGH BLOWER TEMPERATURE OCCURRENCE. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT. A HIGH BLOWER TEMPERATURE OCCURRENCE WILL RESULT IN A VENT INOP CONDITION. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT. THE FIELD SERVICE ENGINEER REPORTED THE BLOWER AND MOTOR CONTROLLER PCB BOARD WERE REPLACED, AND THE REPORTED PROBLEM RESOLVED. FAILURE ANALYSIS ON THE BLOWER AND MOTOR CONTROLLER BOARD SHOWS THAT NO PROBLEM FOUND WITH THE RETURN PARTS. THE REPORTED PROBLEM WAS NOT DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580005 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1