BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2223120 · Received August 25, 2011

    Report

    Report Number
    2031642-2011-00295
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN WHILE ON A PATIENT, AND WHEN IT WAS RESTARTED THE AIR FLOW WASN'T CONSTANT. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE MOTOR CONTROLLER PCB BOARD TO COMPLETE THE REPAIR. FINAL APPLICABLE TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS. FACTORY ANALYSIS REVEALED A COMPONENT FAILURE ON THE MOTOR CONTROLLER PCB BOARD. THE COMPONENT FAILURE RESULTED IN VOLTAGE FLUCTUATION TO THE BLOWER MOTOR, CREATING FLOW AND PRESSURE FLUCTUATION DURING BREATH CYCLING IN NORMAL VENTILATION MODE.

    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