BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 2770649 · Received October 3, 2012

    Report

    Report Number
    2031642-2012-00435
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 21, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WOULD NOT POWER ON. THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT. UPON EVALUATION, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE DEVICE WENT VENT INOP WHEN FIRST POWERED ON INTO NORMAL VENTILATION MODE. THE SERVICE TECHNICIAN REPORTED THE UNIT PASSED EXTENDED SELF TESTING (EST) AND THE VENT INOP OCCURRENCE COULD NOT BE DUPLICATED AFTER EST WAS COMPLETED. REVIEW OF THE DEVICE DIAGNOSTIC LOG INDICATED A 24/12 VOLT FAILURE OCCURENCE DURING OPERATION WITH A VENT INOP OCCURRENCE DURING SUBSEQUENT POWER ON. IF A 24/12 VOLT FAILURE OF THE VENTILATOR OCCURS DURING USE AND RESULTS IN A SHUTDOWN OF THE VENTILATOR, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE. PERFORMANCE VERIFICATION TESTING AND APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1