BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 2414640 · Received January 11, 2012

    Report

    Report Number
    2921601-2011-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    April 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CAREGIVER (MOTHER) REPORTED 50' TUBING SET IN USE TO DELIVER OXYGEN TO (B)(6) "BURST". THE CHILD'S BLOOD GAS LEVELS DROPPED. THE MOTHER NOTICED BECAUSE THE CHILD "TURNED BLUE". THE EVENT WAS ORIGINALLY REPORTED TO THE SUPPLIER OF THE OXYGEN, VITAL AIR, WHO FORWARDED THE INFO TO SALTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALTER LABS 50' TUBING CAT SALTER LABS 2050 060908

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention