BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MON-A-THERM ESOPHAGEAL STETHOSCOPE, 18 FR.

    MDR report key: 50684 · Received September 21, 1996

    Report

    Report Number
    9681384-1996-00006
    Event Type
    Malfunction
    Date Received
    September 21, 1996
    Date of Event
    August 9, 1996
    Report Date
    September 20, 1996
    Manufacturer
    MMJ SA DE C.V. PLANT 1
    Product Code
    BZW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS IN USE FOR AT LEAST 2 HOURS. AT THE END OF THE PROCEDURE, THE ESOPHAGEAL STETHOSCOPE WAS REMOVED. AS THE TUBE WAS REMOVED, THE BALLOON DISCONNECTED FROM THE TUBE AS IT WAS JUST ABOVE THE VOCAL CORDS. THE BALLOON WAS EASILY REMOVED AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MON-A-THERM ESOPHAGEAL STETHOSCOPE, 18 FR. ESOPHAGEAL STETHOSCOPE BZW MMJ SA DE C.V. PLANT 1 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other