BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3820184 · Received April 4, 2014

    Report

    Report Number
    2031642-2014-00236
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    March 13, 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 THE VENTILATOR ALARMED AND DISPLAYED A VENT INOP DATA ACQUISITION PCBA ADC FAILURE MESSAGE. THE CUSTOMER REPORTED THE UNIT WAS IN USE ON A PT AND THERE WAS NO PT HARM. A VENT INOP CONDITION DURING NORMAL VENTILATION OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDE CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. THE MFR'S SERVICE TECH WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. REVIEW OF THE DEVICE DIAGNOSTIC LOG NOTED DATA ACQUISITION PCBA ADC FAILURE OCCURRENCES AS REPORTED. THE SERVICE TECH REPLACED THE DATA ACQUISITION PCB BOARD TO ADDRESS THE FINDINGS AND REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED TO OPERATING SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205298 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1