BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1070511 · Received July 7, 2008

    Report

    Report Number
    2031642-2008-00155
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS UNPLUGGED FROM THE WALL TO MOVE A PT AND THE UNIT WENT VENT INOP AND ALARMED. THE CUSTOMER REPORTED THERE WAS NO PT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED VENT INOP; HOWEVER, THE SERVICE TECHNICIAN CONFIRMED THAT WHILE RUNNING ON THE EXTERNAL BATTERY, THE VENTILATOR WOULD OPERATE FOR LESS THAN 5 MINUTES. THE SERVICE TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A +24 VOLT FAILURE WITH A FOLLOWING VENT INOP. THE SERVICE TECHNICIAN REPLACED THE EXTERNAL BATTERY TO CORRECT THE FINDINGS. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED TO 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 UNK