BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN BRAND OF SALTER HUMIDIFIER DEVICE

    MDR report key: 2188648 · Received August 1, 2011

    Report

    Report Number
    2921601-2011-00002
    Event Type
    Death
    Date Received
    August 1, 2011
    Date of Event
    November 18, 2010
    Report Date
    April 5, 2011
    Manufacturer
    SALTER LABS
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DEVICE MANUFACTURER PHILIPS RESPIRONICS REPORTED TO SALTER LABS ON (B)(6) 2011 THAT AN ADVERSE EVENT INVOLVING A PT DEATH HAD TAKEN PLACE ON (B)(6) 2010 WHILE THE PT WAS USING A PHILIPS RESPIRONICS OXYGEN CONCENTRATOR DEVICE ALONG WITH A SALTER LABS HUMIDIFIER DEVICE. THE PT, LOCATION, AGE, ETC IS NOT KNOWN AND HAS NOT BEEN PROVIDED BY RESPIRONICS. ALSO, THE MANUFACTURER OF THE TUBING AND CANNULA IS UNK. SALTER LABS IS WORKING WITH RESPIRONICS TO OBTAIN PT INFO, SALTER LABS HUMIDIFIER INFO AND RESPIRONICS OXYGEN CONCENTRATOR INFO. THIS IS AN INTERIM REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BRAND OF SALTER HUMIDIFIER DEVICE UNKNOWN SALTER HUMIDIFIER DEVICE BTT SALTER LABS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death