BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 1242884 · Received November 19, 2008

    Report

    Report Number
    2518422-2008-00028
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K832467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTIVE MAINTENANCE AT A MANUFACTURER'S SERVICE CENTER, THE AUDIBLE ALARM OF A VENTILATOR FAILED TO ANNUNCIATE AS DESIGNED. THE CUSTOMER DID NOT ALLEGE ANY PROBLEMS WITH THE DEVICE, ITS ALARM, OR ANY HARM OR INJURY AS A RESULT OF THE USE OF THE PRODUCT. THE MANUFACTURER HAS INITIATED AN INVESTIGATION INTO THE DEVICE'S ALARM FAILURE AND WILL FILE A FOLLOW-UP REPORT WHEN IT IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS, FACILITY USE PLV-100 CBK RESPIRONICS, INC. 35006

    Patients

    Seq Age Sex Outcome Treatment
    1