BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV CONTINUUM II VENTILATOR

    MDR report key: 2573152 · Received May 14, 2012

    Report

    Report Number
    2031642-2012-00224
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 24, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K034032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: NOU.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE DEVICE UPON RETURN FROM THE CUSTOMER, REVIEW OF THE VENTILATOR EVENT LOG NOTED A VENT INOP OCCURRENCE DUE TO A 24V MONITOR FAILURE AND LOSS OF POWER DUE TO USER ERROR IN ALLOWING BATTERY TO DEPLETE DURING OPERATION. THE OCCURRENCES WERE NOT REPORTED BY THE CUSTOMER, AND THERE WAS NO PATIENT HARM REPORTED. THE VENT INOP INDICATOR SIGNALS THE OPERATOR THAT THE VENTILATOR IS NOT CAPABLE OF SUPPORTING VENTILATION AND REQUIRES SERVICE. THE MAIN PCB BOARD WILL BE REPLACED DURING COMPLETION OF SERVICE TO ADDRESS THE FINDING.

    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