BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHAGEAL STETHOSCOPE

    MDR report key: 134195 · Received November 19, 1997

    Report

    Report Number
    134195
    Event Type
    Injury
    Date Received
    November 19, 1997
    Date of Event
    October 20, 1997
    Report Date
    October 26, 1997
    Manufacturer
    RESPIRATORY SUPPORT PRODUCTS, INC.
    Product Code
    BZW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ESOPHAGEAL STETHOSCOPE MALE LUER CONNECTION WAS MISTAKEN FOR A SIMILAR CONNECTION OF AN OXYGEN DELIVERY DEVICE. THE OXYGEN FLOW IMMEDIATELY INFLATED THE STETHOSCOPE MEMBRANE AND RUPTURED IT. THE FORCE CAUSED AN ESOPHAGUS PERFORATION THAT REQUIRED SURGICAL REPAIR. AT THE END OF ON ORTHOPEDIC PROCEDURE, THE 62 Y/O FEMALE PT, WEIGHT UNREPORTED, BECAME AGITATED. THE CRNA MISTAKENLY ADMINISTERED OXYGEN (FLOW: 6 LITERS/MINUTE) TO THE PT THROUGH THE ESOPHAGEAL STETHOSCOPE INSTEAD OF THROUGH THE NASAL CLIP. THE NASAL CLIP HAD A CLEAR TAPERED MALE LUER CONNECTOR ON IT. [THE ESOPHAGEAL STETHOSCOPE HAS A WHITE MALE LUER CONNECTOR ON IT. THE CONNECTOR ON THE OXYGEN HOSE IS GREEN.] THE CRNA NOTICED THE MISTAKE IMMEDIATELY. WHEN THE ESOPHAGEAL STETHOSCOPE WAS REMOVED, THE CRNA NOTICED BLOOD ON IT, BUT DISCARDED THE DEVICE. DURING THE PT'S STAY IN THE RECOVERY ROOM, IT WAS OBSERVED THAT SHE WAS HAVING DIFFICULTY BREATHING AND LUNG SOUNDS WERE REDUCED. AN ESOPHAGEAL X-RAY SHOWED A BLUR. A THORACOTOMY WAS PERFORMED. THERE WAS A TEAR IN THE ESOPHAGUS. THE ESOPHAGEAL TEAR WAS CLEAN AND EASY TO SUTURE. ANTIBIOTICS WERE ADMINISTERED IMMEDIATELY DURING SURGERY. THE PT WAS RELEASED FROM HOSPITAL 10/29/97. AFTER THE DIAGNOSIS, THE CRNA RETURNED TO THE OR WHERE THE PROCEDURE WAS PERFORMED AND RETRIEVED THE ESOPHAGEAL STETHOSCOPE FROM THE SURGICAL DEBRIS. SHE OBSERVED A SPLIT IN THE BALLOON. SHE AGAIN THREW THE ESOPHAGEAL STETHOSCOPE IN THE TRASH. SHE REPORTED THE SPLIT IN THE ESOPHAGEL STETHOSCOPE TO HOSPITAL PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHAGEAL STETHOSCOPE STETHOSCOPE, ESOPHAGEAL BZW RESPIRATORY SUPPORT PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R