BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2250182 · Received September 15, 2011

    Report

    Report Number
    2031642-2011-00320
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WHEN THE VENTILATOR ALARMED, THE FACILITY REMOTE ALARM SYSTEM DID NOT ACTIVATE. THE VENTILATOR WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM REPORTED. THE MANUFACTURER'S FIELD SERVICE TECHNICIAN CONFIRMED THE CUSTOMER REPORTED PROBLEM. UPON EVALUATION, THE SERVICE TECHNICIAN REPORTED THE VENTILATOR REMOTE ALARM CONNECTOR WAS LOOSE. THE SERVICE TECHNICIAN REPLACED THE MAIN PCB BOARD TO CORRECT THE REPORTED PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND 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