BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV CONTINUUM II VENTILATOR

    MDR report key: 1531293 · Received November 17, 2009

    Report

    Report Number
    2031642-2009-00251
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    October 25, 2009
    Report Date
    October 29, 2009
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K034032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: NOU.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE VENTILATOR WAS RETURNED TO THE FACTORY FOR EVALUATION. THE CUSTOMER REPORTED PROBLEM COULD NOT BE DUPLICATED DURING TESTING OF THE DEVICE, HOWEVER REVIEW OF THE VENTILATOR EVENT LOG CONFIRMED A VENT INOP DUE TO AN AIR VALVE STUCK OCCURRENCE DURING OPERATION.

    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