BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES400-18

    MDR report key: 467422 · Received June 17, 2003

    Report

    Report Number
    1221261-2003-00040
    Event Type
    Malfunction
    Date Received
    June 17, 2003
    Report Date
    June 17, 2003
    Manufacturer
    LEVEL 1, INC.
    Product Code
    BZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USER FACILITY WENT TO REMOVE THE ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR FROM THE PATIENT, THE LARGE END OF THE SILICONE SHEATH BROKE OFF AND USER FACILITY COULD NOT REMOVE IT FROM THE PATIENT. THE PATIENT PASSED THE PIECE THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ES400-18 TEMPERATURE SENSOR BZT LEVEL 1, INC. ES400-18 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO