BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2160451 · Received July 13, 2011

    Report

    Report Number
    2031642-2011-00225
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    FACTORY FAILURE ANALYSIS OF THE MAIN PCB BOARD REVEALED PHYSICAL DAMAGE AND A BROKEN SOLDER CONNECTION. THE VENTILATOR'S REMOTE ALARM PORT PROVIDES A SIGNAL DURING VENTILATOR ALARM CONDITIONS TO BE SOUNDED AT REMOTE LOCATIONS AWAY FROM THE VENTILATOR. A BROKEN SOLDER CONNECTION OF THE REMOTE ALARM CONNECTOR MAY RESULT IN NO ALARM SOUNDING TO THE CUSTOMER AT A REMOTE STATION IF THERE IS A VENTILATOR ALARM CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1