BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 648098 · Received November 30, 2005

    Report

    Report Number
    2031642-2005-00192
    Event Type
    Other
    Date Received
    November 30, 2005
    Date of Event
    November 11, 2005
    Report Date
    November 11, 2005
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING SAFETY VALVE OPEN (SVO) WHILE IN USE ON A PT. THE CUSTOMER REPORTED THERE WAS NO PT HARM. THE RESPIRONICS SERVICE TECHNICIAN REPORTED HE WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED EVENT. THE SERVICE TECHNICIAN PERFORMED EXTENTED SELF TESTING (EST) WHICH FAILED DUE TO THE HEATED FILTER BACK PRESSURE OUT OF RANGE. THE SERVICE TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN THE VENTILATOR LOG INDICATING THERE WAS PRESSURE DIFFERENTIAL DETECTED BY THE VENTILATOR. A DETECTED OCCLUSION WILL CAUSE THE VENTILATOR TO ALARM AND OPEN THE SAFETY VALVE UNTIL OCCLUSION IS RESOLVED. THE SERVICE TECHNICIAN REPLACED THE REUSABLE EXPIRATORY FILTER TO CORRECT THE PROBLEM. EST WAS REPEATED AND PASSED TO OPERATING SPECIFICATIONS. THE DEVICE PERFORMED TO SPECIFICATION IN THIS CONDITION. FILTER REPLACEMENT MUST BE PERFORMED AT MFR RECOMMENDED INTERVALS. USER MAINTENANCE CONTRIBUTED TO THIS EVENT DUE TO AN OCCLUDED FILTER.

    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 UNKNOWN