BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4222157 · Received November 3, 2014

    Report

    Report Number
    2031642-2014-01343
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT THE VENTILATOR ALARMED DUE TO A VENT INOP DATA ACQUISITION PCB ADC FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS USE ON A PATIENT, BUT NO PATIENT HARM REPORTED. 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 SERVICE TECHNICIAN REPLACED THE DATA ACQUISITION BOARD TO ADDRESS THE REPORTED ISSUE. THE UNIT PASSED ALL APPLICABLE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703006 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1