BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 3222581 · Received July 12, 2013

    Report

    Report Number
    2031642-2013-00334
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 27, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING SERVICE TO THE VENTILATOR, REVIEW OF THE DEVICE DIAGNOSTIC LOG HISTORY NOTED A PREVIOUS AUTOZERO FAILURE OCCURRENCE. THE CUSTOMER DID NOT REPORT THE OCCURRENCE TO THE MANUFACTURER PREVIOUS TO SERVICE OR AT THE TIME OF ITS OCCURRENCE. THERE WAS NO PATIENT HARM REPORTED. AN AUTOZEROING FAILURE MAY AFFECT THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT DURING USE IN NORMAL VENTILATION MODE. THERE WAS NO RECURRENCE OF THE FINDING DURING TESTING. THE MANUFACTURERS SERVICE TECHNICIAN REPORTED APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322680 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1