BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2772134 · Received October 4, 2012

    Report

    Report Number
    2031642-2012-00437
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 24, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP AND ALARMED DURING USE ON A PATIENT DUE TO A DATA ACQUISITION PCBA ADC REFERENCE FAILURE. THE CUSTOMER REPORTED THERE WAS NO PATIENT 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. THE MANUFACTURERS SERVICE TECHNICIAN REPORTED REVIEW OF THE VENTILATOR DIAGNOSTIC LOG HISTORY NOTED AN OCCURRENCE OF THE REPORTED VENT INOP. THE SERVICE TECHNICIAN REPLACED THE DATA ACQUISITION TO MOTOR CONTROLLER PCB CABLE AND THE DATA ACQUISITION BOARD TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1