BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHAGEAL STETHOSCOPE

    MDR report key: 1061697 · Received June 2, 2008

    Report

    Report Number
    1061697
    Event Type
    Malfunction
    Date Received
    June 2, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 2, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BZW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF SURGERY CASE THE CRNA WAS REMOVING THE ESOPHAGEAL STETHOSCOPE AND NOTED THE TIP OF THE PLASTIC SHEATH HAD SEPARATED. THE DETACHED PIECE WAS REMOVED FROM THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR, ESOPHAGEAL BZW SMITHS MEDICAL ASD, INC. ES 400-18 7815

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NO OTHER THERAPIES| NO OTHER THERAPIES