BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 2821148 · Received October 29, 2012

    Report

    Report Number
    MW5027465
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 29, 2012
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON SEPARATION OF A DUAL LUMEN NASAL CANNULA, ONE PORT WAS TO GO TO THE OXYGEN, AND THE OTHER PORT WAS TO GO TO THE ETC02 MONITOR. THE INPUT OF THE O2 PORTION BECAME LOOSE AND FELL AWAY FROM THE CANNULA, CAUSING THE PT NOT TO BE HOOKED TO THE O2. NO HARM CAME TO THE PT, HOWEVER, THIS WAS A CONCERN. THE COMPANY WAS CONTACTED TO NOTIFY COMPANY ABOUT THIS ISSUE. ASK COMPANY IF THIS IS A PRODUCT DEFECT. ASK COMPANY IF THERE SHOULD BE WARNING RELATED TO HOW FAR BACK YOU SHOULD SEPARATE THE CANNULA LUMENS. ASK COMPANY TO ALERT OTHERS RE: THIS ISSUE. ASK IF COMPANY IS MONITORING SIMILAR OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALTER LABS DOUBLE-LUMEN NASAL CANNULA- ADULT FOR END TIDAL CAT SALTER LABS 10-073012

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention