BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STETHOSCOPE ESOPHAGEAL WITH ELECTRICAL CONDUCTORS

    MDR report key: 734485 · Received June 5, 2006

    Report

    Report Number
    1221261-2006-00017
    Event Type
    Malfunction
    Date Received
    June 5, 2006
    Date of Event
    April 3, 2006
    Report Date
    June 5, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION-OTHER: THE PROBE WAS DISCARDED AT THE FACILITY. SMITHS MEDICAL ASD, INC IS UNABLE TO PERFORM A THOROUGH INVESTIGATION WITHOUT THE RETURN OF THE ACTUAL SAMPLE INVOLVED. IF INFO IS RECEIVED OTHER THAN WHAT IS REPORTED; THEN A FOLLOW UP REPORT WILL BE FILED. A REVIEW OF THE COMPLAINTS DATABASE SHOWS NO REPORTS ON THIS CATALOG NUMBER OR LOT NUMBER. IN ADDITION, A REVIEW OF MFG RECORDS FOR THIS CATALOG NUMBER INDICATED NO PROBLEMS THAT WOULD PROVIDE AN EXPLANATION FOR THIS EVENT.

    Description of Event or Problem · 1

    USER ALLEGES THAT ATTEMPTING TO PULL ESOPHAGEAL PROBE BACK OUT OF THE PT THE WHITE CORD BROKE. THE PROBE WAS REMOVED BY THE DOCTOR "SNAGGING" ESOPHAGEAL STETHOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STETHOSCOPE ESOPHAGEAL WITH ELECTRICAL CONDUCTORS ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR BZT SMITHS MEDICAL ASD, INC. ES400-18 5199

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR