BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2222803 · Received August 25, 2011

    Report

    Report Number
    2031642-2011-00296
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 1, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE VENTILATOR WAS TURNED ON IT HAD A CONSTANT ALARM AND THE MONITOR NEVER CAME ON. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT, THEREFORE WAS NO PATIENT HARM OR INVOLVEMENT. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE CPU PCB BOARD TO ADDRESS THE REPORTED PROBLEM. FINAL APPLICABLE TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS. FACTORY ANALYSIS REVEALED A COMPONENT FAILURE ON THE CPU BOARD. THE COMPONENT FAILURE MAY RESULT IN SHUT DOWN OF THE VENTILATOR DURING NORMAL VENTILATION MODE OPERATION.

    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