BEUDAMED
    FDA Adverse Event Death Summary report: N

    SALTER LABS CONNECTOR

    MDR report key: 4289106 · Received November 25, 2014

    Report

    Report Number
    3000219639-2014-00011
    Event Type
    Death
    Date Received
    November 25, 2014
    Date of Event
    June 2, 2012
    Report Date
    November 25, 2014
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON 11/20/2014 SALTER LABS WAS INFORMED OF AN EVENT THAT OCCURRED ON (B)(6) 2012. THIS IS THE FIRST TIME THAT SALTER LABS HAS RECEIVED THIS INFORMATION. NATURE OF THE EVENT: A PT'S FAMILY REPORTED THAT A PT WAS USING OXYGEN EQUIPMENT WHEN SUDDENLY, AND WITHOUT WARNING, THE EQUIPMENT CAUGHT FIRE AND EXPLODED CAUSING SIGNIFICANT INJURIES INCLUDING BURNS TO THE PT'S FACE AND BODY. THE PT DIED A DAY AFTER OF THIS INCIDENT. THE OXYGEN EQUIPMENT INCLUDED: OXYGEN CONCENTRATOR (NON-SALTER LABS BRANDED), TWO CANNULAS (NON-SALTER LABS BRANDED), A 25' OXYGEN TUBING CONNECTOR (NON-SALTER LABS BRANDED), AND A CONNECTOR SALTER LABS BRANDED. SALTER LABS HAS NOT RECEIVED THE CONNECTOR FOR ANALYSIS. SALTER LABS HAS NOT HAD ANY COMPLAINTS REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766002 SALTER LABS CONNECTOR CONNECTOR CAT SALTER LABS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death AND TWO CANNULAS.| INCLUDED AN OXYGEN CONCENTRATOR, 25' TUBING,| THE CONNECTOR WAS PART OF AN OXYGEN CIRCUIT THAT