BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2942061 · Received February 4, 2013

    Report

    Report Number
    2031642-2013-00050
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 23, 2013
    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

    Additional Manufacturer Narrative · 1

    CHECK VALVE.

    Description of Event or Problem · 1

    WHILE ONSITE TO PERFORM PREVENTIVE MAINTENANCE, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE VENTILATOR WOULD NOT PASS EXTENDED SELF TESTING (EST) DUE TO A LEAK AT THE INSPIRATORY NON-REBREATHING CHECK VALVE. THE VENTILATOR WAS NOT IN USE ON A PATIENT. DURING EVALUATION, THE SERVICE TECHNICIAN REPORTED THE CHECK VALVE BODY WAS FOUND DETACHED FROM THE RING. THE SERVICE TECHNICIAN REPLACED THE CHECK VALVE AND INSPIRATORY MODULE TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46037 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1