BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT ECO TRACHEOSTOMY MASEK

    MDR report key: 3282908 · Received August 6, 2013

    Report

    Report Number
    1319447-2013-00001
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Report Date
    August 6, 2013
    Manufacturer
    INTERSURGICAL, INC.
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A PRODUCT EVALUATION IT WAS OBSERVED THAT THE PATIENT IS NOT RECEIVING PROPER OXYGEN AND THE OXYGENATION LEVEL'S HAVE BEEN IN THE 70'S WHEN NOTICED MASK WAS NOT IN ITS PROPER PLACE. THE CLINICIAN PUT THE MASK BACK ON HIM CORRECTLY AND HIS SATURATION LEVELS INCREASED QUICKLY. THERE WAS NO INJURY OR COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369727 ADULT ECO TRACHEOSTOMY MASEK TRACHEOSTOMY MASK BYG INTERSURGICAL, INC. 1200050 31253814

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention