BEUDAMED
    FDA Adverse Event Death Summary report: N

    SALTER LABS HUMIDIFIER

    MDR report key: 4192787 · Received October 20, 2014

    Report

    Report Number
    3000219639-2014-00008
    Event Type
    Death
    Date Received
    October 20, 2014
    Date of Event
    July 24, 2013
    Report Date
    October 20, 2014
    Manufacturer
    SALTER LABS
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, SALTER LABS BECAME AWARE OF A DEATH OF A PATIENT IN THE (B)(6). THE PATIENT WAS REPORTEDLY USING A SALTER LAB HUMIDIFIER CONNECTED TO AN INVACARE OXYGEN CONCENTRATOR. THE HUMIDIFIER WAS REPORTED TO HAVE BEEN BUBBLING, BUT THE CAP WAS IMPROPERLY ENGAGED, AND SCREWED AND TIGHTENED, ONTO THE BOTTLE, WHICH MAY HAVE RESULTED IN A LEAK. SALTER LABS HAS REQUESTED THAT THE HUMIDIFIER BE RETURNED TO SALTER LABS, OR OTHERWISE BE MADE AVAILABLE FOR OUR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667081 SALTER LABS HUMIDIFIER BUBBLE HUMIDIFIER BTT SALTER LABS E7600-0

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death