BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3250331 · Received July 26, 2013

    Report

    Report Number
    2031642-2013-00364
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 13, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD NOT POWER ON. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT. REVIEW OF THE DEVICE DIAGNOSTIC LOG NOTED A POWER FAIL OCCURRENCE DURING OPERATION. DURING EVALUATION AND TESTING, THE MANUFACTURER'S FIELD SERVICE ENGINEER REPORTED THE POWER SUPPLY VOLTAGES WERE OUT OF SPECIFICATION. THE SERVICE ENGINEER REPLACED THE POWER SUPPLY AND MAIN PCB BOARD TO ADDRESS THE REPORTED PROBLEM AND FINDINGS. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351297 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1