BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE

    MDR report key: 320037 · Received March 9, 2001

    Report

    Report Number
    2020364-2001-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2001
    Date of Event
    February 1, 2001
    Report Date
    February 5, 2001
    Manufacturer
    SIMS PORTEX INC.
    Product Code
    BZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ESOPHAGEAL STETHOSCOPE WAS USED DURING SURGERY. ONE DAY POST-OP, THE PT ALLEGEDLY COUGHED UP THE BALLOON THAT WAS ATTACHED TO THE DISTAL END OF THE ESOPHAGEAL STETHOSCOPE. THE HOSPITAL STAFF WERE REPORTEDLY UNAWARE OF ANY PROBLEMS PRIOR THE PT COUGHING UP THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10335 ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE ESOPHAGEAL STETHOSCOPE BZW SIMS PORTEX INC. NA 1382

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO ENDOTRACHEAL TUBE (2/2001 TO 2/2001).