BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1221704 · Received November 7, 2008

    Report

    Report Number
    2031642-2008-00226
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K051262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    WHILE SERVICING THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN NOTED A DIAGNOSTIC CODE IN THE VENTILATOR'S LOG HISTORY INDICATING AN OXYGEN VALVE STUCK CLOSED. THE CUSTOMER DID NOT REPORT THE OCCURRENCE DURING ANY PREVIOUS USAGE. WHEN QUESTIONED ABOUT THE FINDING, THE CUSTOMER REPORTED THEY WERE UNSURE IF THE VENTILATOR WAS IN USE AT THE TIME, HOWEVER THERE WAS NO PATIENT HARM REPORTED. THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE FINDING. EXTENDED SELF TESTING (EST) AND APPLICABLE TESTING WAS PERFORMED AND ALL TESTING PASSED PER OPERATING SPECIFICATIONS.

    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