BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4182542 · Received October 17, 2014

    Report

    Report Number
    2031642-2014-01247
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 24, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURER'S SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE ALARMED AND DISPLAYED CODES THAT INDICATED A SPI BUS FAILURE. THE SPI BUS IS COMMUNICATION USED TO READ DATA FOR PRESSURE AND FLOW SENSORS. THIS FAILURE MAY RESULT IN A VENT INOP OCCURRENCE. A VENT INOP DURING NORMAL VENTILATION OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT (PSE) FOR ASSISTANCE. PSE ADVISED THE BIOMEDICAL ENGINEER EVALUATE THE DATA ACQUISITION PCB BOARD AND THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB CABLE TO ADDRESS THE REPORTED PROBLEM. THE BIOMEDICAL ENGINEER REPORTED BOTH PARTS WERE REPLACED AS ADVISED AND THE REPORTED PROBLEM RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660492 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1