BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4133221 · Received October 1, 2014

    Report

    Report Number
    2031642-2014-01127
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THAT THE VENTILATOR ALARMED AND WENT VENT INOP DUE TO A DATA ACQUISITION PCBA ADC REFERENCE FAILURE. 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. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE FACILITY BIOMEDICAL ENGINEER REPORTED REPLACING THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB CABLE AND DATA ACQUISITION PCB BOARD AND THE REPORTED PROBLEM WAS RESOLVED AND THE UNIT PLACED BACK INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611697 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1