BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV CONTINUUM II VENTILATOR

    MDR report key: 1789762 · Received August 9, 2010

    Report

    Report Number
    2031642-2010-00211
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 17, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K034032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: NOU. DEVICE BEING RETURNED TO FACTORY FOR ANALYSIS; EVALUATION NOT YET BEGUN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP AND ALARMED DURING OPERATION. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE VENTILATOR IS BEING RETURNED TO THE FACTORY FOR EVALUATION. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT AND THE VENTILATOR SHOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLV CONTINUUM II VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. P2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1