BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRASOUND

    MDR report key: 7347901 · Received March 18, 2018

    Report

    Report Number
    3019216-2018-00020
    Event Type
    Death
    Date Received
    March 18, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 20, 2018
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K030455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE TRANSDUCER AND ADDITIONAL DETAILS FROM THE INCIDENT WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS RETURN AND INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION REVEALED AN ENTEROBACTER CLOACAE OUTBREAK AT THIS HOSPITAL WAS REPORTED TO THE AGENCY OF CARE AND HEALTH ON (B)(6) 2017 AND THE (B)(6) ON (B)(6) 2018. ADDITIONAL INFORMATION OBTAINED FOR THIS INCIDENT EXPOSED A PATIENT DEATH OCCURRED AS A DIRECT RESULT OF THIS BACTERIAL CONTAMINATION AFTER UNDERGOING SEVERAL EXAMINATIONS WITH VARIOUS TRANSESOPHAGEAL (TEE) TRANSDUCERS IN BOTH THE OPERATING ROOM AND INTENSIVE CARE UNIT. THE CUSTOMER COULD NOT CONFIDENTLY IDENTIFY WHICH TRANSDUCER(S) WERE CONTAMINATED. THE CUSTOMER HAS RETAINED THE SUSPECT X7-2T TRANSDUCER AND WILL USE PROTECTIVE SLEEVES TO REDUCE THE LIKELIHOOD OF CONTAMINATION. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A RETURN IS NOT ANTICIPATED, NO FAILURE ANALYSIS CAN BE PERFORMED. THE CUSTOMER COULD NOT CONFIDENTLY IDENTIFY WHICH TRANSDUCER(S) WERE CONTAMINATED. THE CUSTOMER HAS RETAINED THE SUSPECT X7-2T TRANSDUCER AND WILL USE PROTECTIVE SLEEVES TO REDUCE THE LIKELIHOOD OF CONTAMINATION. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A RETURN IS NOT ANTICIPATED, NO FAILURE ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN ENTEROBACTERIA CONTAMINATION WAS FOUND IN THEIR ICU DEPARTMENT. THE SITE¿S INTERNAL DEPARTMENT FOR THE PREVENTION OF INFECTIOUS DISEASES IDENTIFIED AN X7-2T MODEL TRANSDUCER AS A POSSIBLE CAUSE OF THE INFECTION. AN INITIAL VISUAL INSPECTION BY THE SITE NOTED A SMALL PART OF THE DEVICE¿S RTV BEAD WAS MISSING. THE SUSPECT TRANSDUCER HAS BEEN REMOVED FROM SERVICE. NO FURTHER INFORMATION REGARDING PATIENT CONDITION COULD BE OBTAINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190803 ULTRASOUND ITX PHILIPS ULTRASOUND, INC 989605414121 B16DMH

    Patients

    Seq Age Sex Outcome Treatment
    1