BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4122276 · Received September 26, 2014

    Report

    Report Number
    2031642-2014-01110
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 2, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AT STARTUP DURING SETUP FOR USE DUE TO A PRESSURE SENSORS FAILURE. THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. FAILURE OF THE PRESSURE SENSORS DURING NORMAL VENTILATION OPERATION MAY AFFECT THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT, WHICH MAY RESULT IN A VENT INOP OCCURRENCE. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT (PSE) FOR ASSISTANCE. THE BIOMEDICAL ENGINEER REPORTED THE HE DATA ACQUISITION PCB BOARD WAS FAULTY. PSE ADVISED THE BIOMEDICAL ENGINEER REPLACE THE DATA ACQUISITION PCB BOARD. THE BIOMEDICAL ENGINEER REPORTED THE DATA ACQUISITION PCB BOARD WAS REPLACED AND THE REPORTED PROBLEM WAS CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600868 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1