BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1912578 · Received December 2, 2010

    Report

    Report Number
    2031642-2010-00329
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLOWER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. UPON VISUAL INSPECTION AND EVALUATION OF THE UNIT, THE SERVICE TECHNICIAN REPORTED FINDING BLOWER NUTS AND WASHERS HAD LOOSENED AND WERE DETACHED. THE SERVICE TECHNICIAN REPLACED THE BLOWER TO CORRECT THE FINDING. VENT INOP DURING USE, SECONDARY TO THE REPORTED FINDING, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. EXTENDED SELF TESTING AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS 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