BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALTER LABS BUBBLE HUMIDIFIER

    MDR report key: 3108954 · Received May 7, 2013

    Report

    Report Number
    2921601-2013-00004
    Event Type
    Other
    Date Received
    May 7, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SALTER LABS
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED FROM A HOME CARE DISTRIBUTOR ON (B)(6) 2013 REGARDING A PATIENT WHO STATED THAT SHE "FILLED HER BUBBLE HUMIDIFIER TO THE LINE ON THE BOTTLE AND BELIEVES THAT WATER MADE OUT OF THE BOTTLE IN TO HER CANNULA." THE PATIENT ALSO REPORTED THAT SHE "SPENT NUMEROUS DAYS IN THE HOSPITAL WITH WATER IN HER LUNGS DUE TO THE HUMIDIFIER." THE HOME CARE DISTRIBUTOR BELIEVED TO ALSO HAVE FILED MEDICAL DEVICE REPORT FOR THIS INCIDENT. IT IS IMPORTANT TO NOTE THAT THE PRODUCT IN QUESTION IS NOT AVAILABLE FOR RETURN TO SALTER LABS FOR EVALUATIONS, NOR IS THE LOT NUMBER FOR THE PRODUCT AVAILABLE. PERHAPS IMPORTANT TO NOTE IS THAT THERE ARE DESIGN FEATURES THAT PREVENT CONDENSATION FROM COLLECTING IN THE HOSE; HOWEVER, FILING THE HUMIDIFIER ABOVE THE MAXIMUM FILL LINE CAN POTENTIALLY CAUSE CONDENSATION TO COLLECT IN THE HOSE. WITHOUT EVALUATING THE SPECIFIC PRODUCT IN QUESTION, IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT OR DETERMINE A ROOT CAUSE, IF APPLICABLE. THIS IS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199976 SALTER LABS BUBBLE HUMIDIFIER BUBBLE HUMIDIFIER BTT SALTER LABS 7600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other