BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1913161 · Received December 2, 2010

    Report

    Report Number
    2031642-2010-00323
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FILTER.

    Description of Event or Problem · 1

    WHILE ONSITE FOR PREVENTIVE MAINTENANCE, THE MANUFACTURER'S SERVICE TECHNICIAN PERFORMED BACK PRESSURE TESTING OF THE EXHALATION FILTER. THE SERVICE TECHNICIAN REPORTED THE FILTER FAILED THE TEST WITH PRESSURE >4CMH2O INDICATING AN OCCLUDED FILTER, AND THERE WAS DEBRIS NOTED INSIDE THE FILTER. AS SPECIFIED, A DETECTED OCCLUSION WILL CAUSE THE VENTILATOR TO ALARM AND OPEN THE SAFETY VALVE UNTIL THE OCCLUSION IS RESOLVED. THE RESPIRATORY TECHNICIAN STATED THAT FILTERS ARE NOT BEING CHANGED AS SPECIFIED PER MANUFACTURER INSTRUCTIONS FOR USE. THE SERVICE TECHNICIAN REPLACED THE EXPIRATORY FILTER TO ADDRESS THE FINDING. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS. USER MAINTENANCE CONTRIBUTED TO THIS EVENT. FILTER MAINTENANCE AND REPLACEMENT MUST BE PERFORMED PER MANUFACTURER RECOMMENDATIONS AND AT SPECIFIED INTERVALS. THE CUSTOMER DID NOT REPORT THE FINDING DURING ANY PREVIOUS USAGE. THE UNIT WAS NOT IN USE ON A PATIENT, THEREFORE THERE WAS NO PATIENT INVOLVEMENT.

    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 EXPIRATORY FILTER