BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT ARIES CO2 BLOWER/MISTER

    MDR report key: 1023494 · Received April 2, 2008

    Report

    Report Number
    2953148-2008-00317
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    FQH
    PMA / PMN Number
    K983135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. SINCE THE PRODUCT WAS NOT RETURNED TO CARDIAC SURGERY FOR EVAL, IT WILL BE DIFFICULT TO CONFIRM THE REPORTED PROBLEM. FOR LHR REVIEW AT THE OEM END, NEW REQUIREMENTS ARE BEING ESTABLISHED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE PREP FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, THE BLOWER/MISTER MIST FLUCTUATED HIGH THEN EXTREMELY LOW THROUGHOUT THE PROCEDURE AND WOULD NOT STAY CONSISTENT. STAFF DID NOT CHANGE ANY SETTINGS DURING THIS TIME. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO PT CONSEQUENCES. HIGH MIST PRESSURE FLOW RATE IS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT ARIES CO2 BLOWER/MISTER FQH GUIDANT CARDIAC SURGERY CB-1000 96255207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA