BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 6 PLUS

    MDR report key: 3354111 · Received September 12, 2013

    Report

    Report Number
    3354111
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    August 6, 2013
    Report Date
    September 12, 2013
    Manufacturer
    GE HEALTHCARE, LLC
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PER THE RE-CALL, LOW PRESSURE LEAK TEST WAS ASKED TO BE VALIDATED. 20/20 OF OUR PIECES FAILED. WE ARE CURRENTLY WORKING WITH GE ON SERVICE AND REPLACEMENT. ====================== MANUFACTURER RESPONSE FOR TEC 6 PLUS VAPORIZER, TEC 6 VAPORIZER (PER SITE REPORTER).====================== WE ARE WAITING FOR GE TO REPAIR/REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460008 TEC 6 PLUS VAPORIZER CAD GE HEALTHCARE, LLC TEC 6 VAPORIZER *

    Patients

    Seq Age Sex Outcome Treatment
    1 *