BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 4957430 · Received July 31, 2015

    Report

    Report Number
    2031702-2015-00154
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    July 31, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS AND PASSED THE INITIAL ALARM VOLUME TEST. DURING THE INITIAL FINAL TEST, THE VENTILATOR HAD A NON-CONFORMANCE WITH MEASURED PEEP AT PTV PRESSURE PERFORMANCE TEST 5. THE MEASURED PEEP WAS 2.8 CMH2O AND THE EXPECTED PEEP WAS BETWEEN 4.0 CMH2O TO 6.0 CMH2O. A VISUAL INSPECTION REVEALED THE PRESENCE OF AN UNKNOWN CONTAMINANT ON FLOW SENSOR FILTER, AIR INLET FILTER, AND THE BLOWER INLET FILTER. THIS NON-CONFORMANCE THAT WAS FOUND DURING TESTING IS UNRELATED TO THE REPORTED EVENT. THE AIR INLET FILTER, BLOWER INLET FILTER, AND FLOW SENSOR FILTER WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS ALARMING SVHP RELIEF (SAFETY VALVE HIGH PRESSURE RELIEF ALARM). THERE WAS NO PATIENT INVOLVED IN THE REPORTED EVENT AS THE ISSUE WAS DISCOVERED DURING PATIENT TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501407 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1