BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4170501 · Received October 14, 2014

    Report

    Report Number
    2031642-2014-01207
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DUE TO A VENT INOP DATA ACQUISITION PCBA ADC REFERENCE FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. A VENT INOP CONDITION DURING 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. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT ENGINEER (PSE) FOR ASSISTANCE. PSE ADVISED THE BIOMEDICAL ENGINEER TEST THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB BOARD CABLE. THE BIOMEDICAL ENGINEER REPORTED DURING TESTING OF THE CABLE THE REPORTED PROBLEM WAS DUPLICATED. PSE ADVISED THE BIOMEDICAL ENGINEER TO REPLACE THE CABLE TO ADDRESS THE REPORTED PROBLEM. THE BIOMEDICAL ENGINEER REPORTED THE CABLE WAS REPLACED AS ADVISED AND THE REPORTED PROBLEM WAS CORRECTED. THE BIOMEDICAL ENGINEER REPORTED THE UNIT PASSED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651603 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1