BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER X8-2T

    MDR report key: 19905412 · Received August 5, 2024

    Report

    Report Number
    19905412
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    May 24, 2024
    Report Date
    May 29, 2024
    Manufacturer
    PHILIPS ULTRASOUND LLC
    Product Code
    ITX
    UDI-DI
    00884838069718
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SITUATION: TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE RUBBER SHEATH WAS NOT INTACT WHEN PROBE REMOVED FROM PATIENT¿S ESOPHAGUS AT THE END OF PROCEDURE. TEE PROBE WAS INTACT PRIOR TO INSERTION. BACKGROUND: PATIENT UNDERWENT ROUTINE TEE WITH BITE BLOCK IN PLACE. WHEN PROBE WAS REMOVED AND CARDIOLOGIST PASSED THE PROBE TO ECHO TECH, SHE WIPED IT DOWN AS PER USUAL PRACTICE AND SHE NOTED A 1-1.5¿ PIECE OF THE PROBE COVERING (BLACK, SOFT RUBBER) WAS MISSING. SHE NOTIFIED THE CARDIOLOGIST AND THE REGISTERED NURSE (RN) WHO WERE ALSO AT BEDSIDE AND ALL LOOKED FOR THE PIECE IN THE BED, TRASH, LINEN, ETC. THE MISSING PIECE WAS NOT FOUND. THE PATIENT HAD A CT SCAN AND RESULTS DO NOT SHOW ANY ¿DISCERNABLE RADIOPAQUE FOREIGN OBJECT¿ OR EVIDENCE OF BOWEL OBSTRUCTION. THE TEE PROBE WAS SEQUESTERED AND SUBSEQUENTLY, BIOMED TOOK POSSESSION OF THE PROBE WITH INTENT ON SENDING BACK TO PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781101 TRANSDUCER X8-2T TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND LLC 989605455171 00884838069718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown