BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HME ADULT FILTERED 25/CS

    MDR report key: 2972808 · Received February 21, 2013

    Report

    Report Number
    2050001-2013-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BYD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT PRODUCT OR PICTURES OF THE COMPLAINT PRODUCT ARE NOT AVAILABLE FOR EVALUATION. A FOLLOW UP WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT PROVIDED, AN EVALUATION COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THIS LOT OF PRODUCT. THE DHR REVIEW DID NOT IDENTIFY ANY ISSUES DURING THE MANUFACTURE OF THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    CUSTOMER DISSATISFACTION CUSTOMER REPORTS THAT THE PRODUCT COLLECTS WATER IN USE AND THEY HAVE TO CHANGE IT OUT SEVERAL TIMES A DAY.  ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER ON (B)(6) 2013.  THE CUSTOMER HAS SEEN THIS ISSUE WITH BOTH ENDOTRACHEAL AND TRACH PATIENTS WITH THIS HME.  A HEATER WAS NOT USED WITH THE HME.  THE THERAPISTS JUST CHANGED THE HME AS OFTEN AS NEEDED.  THERE WERE NO  OTHER POTENTIAL SOURCES OR MOISTURE.  THE VENT PATIENT DID NOT RECEIVE AEROSOL NEBS THAT WOULD HAVE CONTRIBUTED.  THE COMPLAINT PRODUCT OR PICTURES OF THE COMPLAINT PRODUCT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76572 HME ADULT FILTERED 25/CS CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) BYD CAREFUSION 003005-A SJ0812004

    Patients

    Seq Age Sex Outcome Treatment
    1